metformin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antihyperglycaemics, phenformin derivatives	1725	657-24-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: metformin metformin hydrochloride glucophage LA-6023 LA 6023 N,N-dimethylguanylguanidine metformin HCl	A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289) Molecular weight: 129.17 Formula: C4H11N5 CLOGP: -1.43 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 88.99 ALOGS: -1.97 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

metformin
metformin hydrochloride
glucophage
LA-6023
LA 6023
N,N-dimethylguanylguanidine
metformin HCl

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

Molecular weight: 129.17
Formula: C4H11N5
CLOGP: -1.43
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 88.99
ALOGS: -1.97
ROTB: 0

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
2	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	99 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	387.10 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	52 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.64 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	7.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.70 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 3, 1995	FDA	BRISTOL MYERS SQUIBB

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Lactic acidosis	18748.23	29.38	3367	13538	1963	2339217
Acute kidney injury	8952.19	29.38	2497	14408	25625	2315555
Hypoglycaemia	5112.64	29.38	1258	15647	7149	2334031
Metabolic acidosis	3957.01	29.38	960	15945	5038	2336142
Diarrhoea	3112.95	29.38	1540	15365	82024	2259156
Completed suicide	2497.01	29.38	890	16015	20144	2321036
Vomiting	2461.14	29.38	1253	15652	70349	2270831
Toxicity to various agents	2338.51	29.38	956	15949	31798	2309382
Hyperkalaemia	1984.29	29.38	554	16351	5339	2335841
Blood glucose increased	1813.65	29.38	613	16292	11677	2329503
Renal failure	1553.15	29.38	598	16307	16751	2324429
Nausea	1543.39	29.38	1091	15814	111098	2230082
Hypotension	1444.77	29.38	681	16224	31755	2309425
Intentional overdose	1379.92	29.38	490	16415	10831	2330349
Diabetes mellitus inadequate control	1269.52	29.38	308	16597	1579	2339601
Exposure during pregnancy	1200.49	29.38	555	16350	24664	2316516
Shock	1190.38	29.38	342	16563	3662	2337518
Dehydration	1058.39	29.38	490	16415	21805	2319375
Overdose	1021.64	29.38	462	16443	19445	2321735
Haemodialysis	994.07	29.38	258	16647	1811	2339369
Anuria	927.58	29.38	238	16667	1586	2339594
Diabetic ketoacidosis	907.20	29.38	270	16635	3294	2337886
Hypothermia	898.45	29.38	240	16665	1908	2339272
Hyperglycaemia	835.50	29.38	273	16632	4612	2336568
Cardiac arrest	776.26	29.38	350	16555	14580	2326600
Pancreatitis acute	768.20	29.38	242	16663	3611	2337569
Blood creatinine increased	721.17	29.38	300	16605	10233	2330947
Drug level increased	708.47	29.38	211	16694	2576	2338604
Glycosylated haemoglobin increased	701.43	29.38	191	16714	1643	2339537
Suicide attempt	701.29	29.38	300	16605	10982	2330198
Hyperlactacidaemia	697.20	29.38	143	16762	266	2340914
Abdominal pain	677.08	29.38	421	16484	33953	2307227
Hypoglycaemic coma	673.16	29.38	147	16758	419	2340761
Maternal exposure during pregnancy	582.92	29.38	287	16618	14576	2326604
Drug interaction	570.87	29.38	356	16549	28807	2312373
Ketoacidosis	564.96	29.38	140	16765	791	2340389
Drug hypersensitivity	562.67	29.38	422	16483	46221	2294959
Renal impairment	544.47	29.38	243	16662	9849	2331331
Multiple organ dysfunction syndrome	517.17	29.38	216	16689	7425	2333755
Confusional state	516.56	29.38	313	16592	24031	2317149
Asthenia	511.92	29.38	400	16505	46526	2294654
Tachypnoea	481.73	29.38	149	16756	2080	2339100
Blood lactic acid increased	461.65	29.38	117	16788	734	2340446
Malaise	458.59	29.38	403	16502	55182	2285998
Pancreatitis	456.45	29.38	201	16704	7878	2333302
Blood glucose decreased	453.53	29.38	156	16749	3096	2338084
Acidosis	422.50	29.38	125	16780	1485	2339695
Coma	422.00	29.38	197	16708	8859	2332321
Somnolence	417.52	29.38	270	16635	23215	2317965
Continuous haemodiafiltration	417.47	29.38	90	16815	236	2340944
Weight decreased	403.51	29.38	284	16621	28087	2313093
Dyspnoea	390.01	29.38	432	16473	78301	2262879
Decreased appetite	389.64	29.38	280	16625	28611	2312569
Drug ineffective	372.37	29.38	478	16427	101146	2240034
Diabetic metabolic decompensation	362.58	29.38	72	16833	103	2341077
Bradycardia	353.42	29.38	180	16725	9801	2331379
Abdominal pain upper	336.95	29.38	231	16674	21869	2319311
Cardio-respiratory arrest	332.73	29.38	168	16737	8978	2332202
Pemphigoid	332.52	29.38	93	16812	889	2340291
Gastrointestinal disorder	324.98	29.38	164	16741	8753	2332427
Vitamin B12 deficiency	324.35	29.38	82	16823	508	2340672
Sopor	304.33	29.38	123	16782	3872	2337308
Poisoning	293.74	29.38	109	16796	2711	2338469
Headache	281.89	29.38	370	16535	79809	2261371
Abdominal discomfort	279.13	29.38	188	16717	17268	2323912
Product complaint	275.99	29.38	119	16786	4419	2336761
Dialysis	275.27	29.38	97	16808	2070	2339110
Tachycardia	265.41	29.38	178	16727	16231	2324949
Condition aggravated	265.25	29.38	233	16672	31746	2309434
Blood potassium increased	258.87	29.38	93	16812	2103	2339077
Foetal exposure during pregnancy	256.16	29.38	118	16787	5134	2336046
Unresponsive to stimuli	254.98	29.38	115	16790	4761	2336419
Dizziness	252.80	29.38	300	16605	58365	2282815
Gastroenteritis	249.64	29.38	99	16806	2961	2338219
Hyperhidrosis	241.51	29.38	164	16741	15258	2325922
Circulatory collapse	240.89	29.38	102	16803	3618	2337562
Depressed level of consciousness	237.15	29.38	126	16779	7478	2333702
Weight increased	233.26	29.38	186	16719	22151	2319029
Loss of consciousness	230.29	29.38	172	16733	18595	2322585
Premature delivery	228.23	29.38	94	16811	3106	2338074
Fall	226.51	29.38	255	16650	46844	2294336
Oliguria	216.26	29.38	72	16833	1285	2339895
Anaemia	212.58	29.38	214	16691	34578	2306602
Hepatic steatosis	211.03	29.38	89	16816	3124	2338056
Blood pressure decreased	209.01	29.38	124	16781	9112	2332068
Diabetes mellitus	208.12	29.38	115	16790	7380	2333800
Intentional product misuse	205.91	29.38	124	16781	9365	2331815
Rhabdomyolysis	200.36	29.38	108	16797	6596	2334584
Urinary tract infection	197.39	29.38	192	16713	29750	2311430
Respiratory failure	193.27	29.38	136	16769	13392	2327788
Pancreatic carcinoma	193.11	29.38	67	16838	1362	2339818
Amylase increased	187.24	29.38	62	16843	1087	2340093
Body temperature decreased	186.42	29.38	64	16841	1259	2339921
Fatigue	184.57	29.38	313	16592	84560	2256620
Exposure via ingestion	184.28	29.38	56	16849	732	2340448
Product residue present	183.92	29.38	61	16844	1075	2340105
Haemodynamic instability	177.74	29.38	60	16845	1119	2340061
Hypomagnesaemia	175.00	29.38	73	16832	2491	2338689
Pharyngitis	174.26	29.38	70	16835	2165	2339015
Medication error	172.75	29.38	95	16810	6036	2335144
General physical health deterioration	169.84	29.38	128	16777	14011	2327169
Anion gap increased	168.82	29.38	42	16863	241	2340939
Blood glucose abnormal	168.25	29.38	59	16846	1239	2339941
Sepsis	167.87	29.38	142	16763	18346	2322834
Electrocardiogram QT prolonged	164.06	29.38	100	16805	7714	2333466
Hypertension	162.82	29.38	166	16739	27195	2313985
Hepatic failure	162.62	29.38	89	16816	5600	2335580
Hepatitis	161.68	29.38	92	16813	6245	2334935
Death	160.83	29.38	288	16617	81180	2260000
Lower respiratory tract infection	158.21	29.38	86	16819	5338	2335842
Pruritus	157.98	29.38	204	16701	43136	2298044
Disorientation	155.86	29.38	90	16815	6282	2334898
Hypovolaemia	153.32	29.38	54	16851	1149	2340031
Toothache	153.08	29.38	67	16838	2577	2338603
Septic shock	152.53	29.38	92	16813	6962	2334218
Caesarean section	151.32	29.38	76	16829	4005	2337175
Pneumonia	150.72	29.38	213	16692	49083	2292097
Blood glucose fluctuation	149.59	29.38	48	16857	758	2340422
Blood bicarbonate decreased	149.33	29.38	43	16862	460	2340720
Blood urea increased	148.13	29.38	72	16833	3533	2337647
Dyspepsia	147.65	29.38	102	16803	9742	2331438
Hypokalaemia	147.26	29.38	105	16800	10549	2330631
Drug intolerance	146.87	29.38	116	16789	13601	2327579
Polyuria	146.62	29.38	52	16853	1130	2340050
Chest pain	146.53	29.38	159	16746	27978	2313202
Poisoning deliberate	146.23	29.38	52	16853	1139	2340041
Live birth	145.86	29.38	53	16852	1238	2339942
Renal tubular necrosis	145.76	29.38	56	16849	1534	2339646
Product substitution issue	144.05	29.38	79	16826	4990	2336190
Respiratory arrest	142.49	29.38	84	16821	6094	2335086
Drug abuse	142.48	29.38	108	16797	11918	2329262
Gait inability	140.05	29.38	82	16823	5873	2335307
Hypophagia	138.13	29.38	71	16834	3929	2337251
Heart rate increased	134.37	29.38	101	16804	11004	2330176
Hyponatraemia	132.68	29.38	108	16797	13217	2327963
Mental status changes	131.63	29.38	77	16828	5505	2335675
Product use in unapproved indication	131.39	29.38	100	16805	11100	2330080
Leukocytosis	127.91	29.38	65	16840	3511	2337669
Pulseless electrical activity	127.21	29.38	45	16860	970	2340210
Hemiplegia	127.06	29.38	49	16856	1356	2339824
Vasoplegia syndrome	126.27	29.38	30	16875	137	2341043
Syncope	125.94	29.38	116	16789	16759	2324421
Dysarthria	125.52	29.38	78	16827	6224	2334956
Adverse drug reaction	124.62	29.38	86	16819	8197	2332983
Agitation	123.79	29.38	96	16809	10955	2330225
Electrolyte imbalance	122.42	29.38	53	16852	1984	2339196
Inappropriate schedule of product administration	121.68	29.38	99	16806	12105	2329075
Atrial fibrillation	121.35	29.38	104	16801	13664	2327516
Personality disorder	120.40	29.38	34	16871	337	2340843
Persistent cloaca	115.63	29.38	20	16885	3	2341177
Abortion spontaneous	115.33	29.38	100	16805	13345	2327835
Blood pH decreased	115.26	29.38	35	16870	456	2340724
Eosinophilia	115.09	29.38	57	16848	2913	2338267
Acute myocardial infarction	114.64	29.38	68	16837	4987	2336193
Pancytopenia	114.38	29.38	93	16812	11359	2329821
Thrombocytopenia	113.60	29.38	116	16789	19015	2322165
Abdominal distension	113.48	29.38	89	16816	10322	2330858
Arthralgia	113.48	29.38	197	16708	54088	2287092
Type 2 diabetes mellitus	112.28	29.38	51	16854	2143	2339037
Drug-induced liver injury	111.62	29.38	60	16845	3639	2337541
Vitamin B12 decreased	110.89	29.38	32	16873	345	2340835
Myocardial infarction	110.57	29.38	114	16791	18899	2322281
Glomerular filtration rate decreased	110.32	29.38	45	16860	1448	2339732
Myalgia	109.63	29.38	125	16780	23208	2317972
Euglycaemic diabetic ketoacidosis	109.56	29.38	27	16878	148	2341032
Electrocardiogram QRS complex prolonged	108.89	29.38	41	16864	1061	2340119
Alanine aminotransferase increased	107.69	29.38	98	16807	13934	2327246
Angioedema	107.46	29.38	79	16826	8317	2332863
Tubulointerstitial nephritis	107.14	29.38	51	16854	2387	2338793
Respiratory rate increased	106.15	29.38	44	16861	1476	2339704
Cold sweat	105.85	29.38	48	16857	2009	2339171
Urticaria	105.67	29.38	125	16780	24136	2317044
Accidental overdose	104.90	29.38	59	16846	3913	2337267
Oedema peripheral	104.43	29.38	123	16782	23640	2317540
Blood pressure systolic increased	103.01	29.38	49	16856	2290	2338890
Postprandial hypoglycaemia	102.97	29.38	18	16887	4	2341176
Aspartate aminotransferase increased	102.54	29.38	91	16814	12521	2328659
Cardiac failure	101.80	29.38	89	16816	12005	2329175
Product prescribing error	100.64	29.38	52	16853	2908	2338272
Hypoaesthesia	99.56	29.38	111	16794	20104	2321076
Intestinal malrotation	98.96	29.38	20	16885	33	2341147
Hypersensitivity vasculitis	98.79	29.38	40	16865	1262	2339918
Conjoined twins	98.63	29.38	18	16887	10	2341170
Respiratory distress	98.40	29.38	62	16843	5067	2336113
Blood creatine phosphokinase increased	98.33	29.38	62	16843	5074	2336106
Cholestasis	97.53	29.38	55	16850	3666	2337514
Encephalopathy	97.32	29.38	59	16846	4502	2336678
Off label use	96.85	29.38	220	16685	73378	2267802
Anhidrosis	96.82	29.38	20	16885	39	2341141
Hepatocellular injury	95.76	29.38	56	16849	3999	2337181
Pancreatic carcinoma metastatic	95.09	29.38	30	16875	447	2340733
Hypovolaemic shock	94.13	29.38	34	16871	780	2340400
Cholelithiasis	93.80	29.38	63	16842	5740	2335440
Pulmonary oedema	93.59	29.38	69	16836	7294	2333886
Gastrooesophageal reflux disease	93.22	29.38	75	16830	9020	2332160
Blood sodium decreased	92.74	29.38	50	16855	3050	2338130
Blood pressure increased	91.88	29.38	98	16807	16888	2324292
Blood pressure diastolic decreased	91.28	29.38	36	16869	1059	2340121
Hyperventilation	90.66	29.38	37	16868	1192	2339988
Coma scale abnormal	90.24	29.38	33	16872	785	2340395
Muscular weakness	89.64	29.38	91	16814	14806	2326374
Cough	89.32	29.38	135	16770	32982	2308198
Pyrexia	88.48	29.38	176	16729	53532	2287648
Renal injury	88.08	29.38	34	16871	943	2340237
Altered state of consciousness	87.72	29.38	52	16853	3808	2337372
Mitral valve incompetence	87.27	29.38	45	16860	2505	2338675
Dysphagia	85.89	29.38	83	16822	12722	2328458
Premature baby	85.71	29.38	48	16857	3156	2338024
Aphasia	85.70	29.38	56	16849	4872	2336308
White blood cell count increased	84.76	29.38	64	16841	7014	2334166
Sinus tachycardia	84.05	29.38	48	16857	3277	2337903
Toxic epidermal necrolysis	83.83	29.38	47	16858	3097	2338083
Lethargy	83.18	29.38	69	16836	8661	2332519
Respiratory disorder	80.84	29.38	50	16855	3954	2337226
Jaundice	80.04	29.38	56	16849	5452	2335728
Vision blurred	79.98	29.38	85	16820	14583	2326597
Urosepsis	79.67	29.38	39	16866	1942	2339238
Diabetic nephropathy	79.60	29.38	22	16883	200	2340980
Renal cyst	79.54	29.38	33	16872	1109	2340071
Presyncope	78.07	29.38	48	16857	3755	2337425
Delirium	78.00	29.38	54	16851	5169	2336011
Urine output decreased	76.75	29.38	35	16870	1484	2339696
Kussmaul respiration	75.61	29.38	16	16889	37	2341143
Haematemesis	74.95	29.38	48	16857	4034	2337146
Incorrect dose administered	74.93	29.38	68	16837	9627	2331553
Hyperthyroidism	74.64	29.38	38	16867	2059	2339121
Anal incontinence	74.61	29.38	36	16869	1736	2339444
Diabetic retinopathy	74.02	29.38	23	16882	325	2340855
Patent ductus arteriosus	73.64	29.38	27	16878	647	2340533
Erythema	72.75	29.38	106	16799	25053	2316127
Urachal abnormality	72.74	29.38	13	16892	5	2341175
Rash	72.74	29.38	173	16732	59385	2281795
Left ventricular hypertrophy	72.23	29.38	27	16878	684	2340496
Chronic kidney disease	72.11	29.38	47	16858	4071	2337109
Product odour abnormal	72.09	29.38	23	16882	356	2340824
Tremor	71.62	29.38	95	16810	20566	2320614
Asthma	71.51	29.38	71	16834	11243	2329937
Systemic infection	70.78	29.38	17	16888	82	2341098
Polyhydramnios	70.66	29.38	22	16883	313	2340867
Gastrointestinal sounds abnormal	70.18	29.38	25	16880	550	2340630
Microalbuminuria	70.11	29.38	17	16888	86	2341094
PCO2 decreased	69.76	29.38	21	16884	265	2340915
Low birth weight baby	68.20	29.38	27	16878	802	2340378
Rectal haemorrhage	68.01	29.38	52	16853	5804	2335376
Blindness transient	67.18	29.38	27	16878	835	2340345
Congenital bladder anomaly	67.01	29.38	13	16892	15	2341165
Swelling face	66.43	29.38	63	16842	9430	2331750
Treatment noncompliance	66.16	29.38	50	16855	5484	2335696
Electrocardiogram T wave peaked	65.97	29.38	15	16890	54	2341126
Muscle spasms	65.47	29.38	93	16812	21473	2319707
Colitis microscopic	65.03	29.38	27	16878	909	2340271
Ischaemic stroke	64.99	29.38	41	16864	3356	2337824
Anaemia megaloblastic	64.72	29.38	16	16889	89	2341091
Pregnancy	63.88	29.38	57	16848	7892	2333288
Anaemia vitamin B12 deficiency	63.58	29.38	15	16890	66	2341114
Anaemia macrocytic	63.14	29.38	21	16884	373	2340807
Hypoxia	63.06	29.38	51	16854	6176	2335004
Product quality issue	63.04	29.38	65	16840	10764	2330416
Hepatic enzyme increased	62.85	29.38	62	16843	9740	2331440
Therapeutic response unexpected	62.61	29.38	42	16863	3817	2337363
Left atrial dilatation	62.60	29.38	19	16886	247	2340933
Hepatic cirrhosis	62.25	29.38	35	16870	2318	2338862
Blood chloride decreased	61.62	29.38	24	16881	682	2340498
Adenocarcinoma pancreas	61.56	29.38	18	16887	204	2340976
Hepatitis acute	61.07	29.38	30	16875	1505	2339675
Haemoglobin decreased	60.67	29.38	82	16823	18069	2323111
Deep vein thrombosis	60.21	29.38	69	16836	12863	2328317
Retching	60.18	29.38	33	16872	2081	2339099
Pain in extremity	60.15	29.38	131	16774	42409	2298771
Hypocalcaemia	59.99	29.38	41	16864	3842	2337338
Chest discomfort	59.89	29.38	73	16832	14522	2326658
Blood phosphorus increased	59.73	29.38	20	16885	363	2340817
Drug reaction with eosinophilia and systemic symptoms	59.73	29.38	47	16858	5471	2335709
Hemiparesis	59.48	29.38	39	16866	3411	2337769
Nephropathy toxic	58.84	29.38	27	16878	1161	2340019
Flatulence	58.83	29.38	43	16862	4482	2336698
Self-medication	58.14	29.38	22	16883	577	2340603
Azotaemia	57.93	29.38	22	16883	583	2340597
Coagulopathy	57.89	29.38	36	16869	2873	2338307
Bradyphrenia	57.66	29.38	26	16879	1073	2340107
Hypoperfusion	57.10	29.38	17	16888	206	2340974
Creatinine renal clearance abnormal	56.92	29.38	14	16891	76	2341104
Cerebrovascular accident	56.82	29.38	84	16821	20102	2321078
Neurologic neglect syndrome	56.76	29.38	14	16891	77	2341103
Constipation	56.61	29.38	87	16818	21542	2319638
Acute respiratory distress syndrome	56.24	29.38	37	16868	3255	2337925
Pancreatitis chronic	56.15	29.38	18	16887	283	2340897
Back pain	56.01	29.38	107	16798	31552	2309628
Vertigo	55.84	29.38	57	16848	9327	2331853
Cholecystitis	55.71	29.38	32	16873	2208	2338972
Electrocardiogram abnormal	55.59	29.38	27	16878	1321	2339859
Allergic reaction to excipient	55.33	29.38	13	16892	56	2341124
Hypersensitivity	54.99	29.38	90	16815	23503	2317677
Product administration error	54.76	29.38	39	16866	3904	2337276
Hepatotoxicity	54.36	29.38	37	16868	3444	2337736
Malabsorption	54.31	29.38	21	16884	585	2340595
Insomnia	54.30	29.38	94	16811	25693	2315487
Restlessness	54.04	29.38	41	16864	4522	2336658
Carotid artery thrombosis	54.00	29.38	14	16891	97	2341083
Duodenal ulcer	53.78	29.38	25	16880	1108	2340072
Cholestatic liver injury	53.71	29.38	17	16888	256	2340924
Dyslipidaemia	53.43	29.38	22	16883	725	2340455
Coma acidotic	53.40	29.38	11	16894	21	2341159
Polydipsia	53.32	29.38	21	16884	615	2340565
Mydriasis	53.32	29.38	31	16874	2188	2338992
Muscle spasticity	53.21	29.38	28	16877	1625	2339555
Intentional self-injury	53.16	29.38	39	16866	4088	2337092
Palpitations	52.96	29.38	73	16832	16383	2324797
Alopecia	52.74	29.38	85	16820	21916	2319264
Prescription drug used without a prescription	52.64	29.38	16	16889	209	2340971
Premature rupture of membranes	52.56	29.38	23	16882	883	2340297
Dry mouth	52.53	29.38	52	16853	8201	2332979
Systemic inflammatory response syndrome	52.48	29.38	22	16883	759	2340421
Anaphylactic reaction	52.46	29.38	56	16849	9649	2331531
Dysentery	52.09	29.38	16	16889	217	2340963
Lipase increased	50.60	29.38	26	16879	1436	2339744
Bronchitis	50.53	29.38	65	16840	13649	2327531
Anxiety	50.42	29.38	98	16807	29261	2311919
Hypertensive heart disease	50.11	29.38	18	16887	406	2340774
Drug level above therapeutic	50.08	29.38	19	16886	502	2340678
Congenital uterine anomaly	49.67	29.38	10	16895	16	2341164
Affect lability	49.54	29.38	29	16876	2073	2339107
Pollakiuria	49.53	29.38	36	16869	3720	2337460
Maternal drugs affecting foetus	49.21	29.38	26	16879	1521	2339659
Gestational diabetes	48.97	29.38	25	16880	1362	2339818
Small for dates baby	48.92	29.38	20	16885	647	2340533
Hypoglycaemia neonatal	48.80	29.38	15	16890	204	2340976
Disseminated intravascular coagulation	48.53	29.38	34	16871	3316	2337864
Glycosylated haemoglobin decreased	48.29	29.38	13	16892	106	2341074
Prerenal failure	48.27	29.38	15	16890	212	2340968
Respiratory acidosis	48.14	29.38	21	16884	800	2340380
Nephropathy	47.92	29.38	21	16884	809	2340371
Normal newborn	47.56	29.38	24	16881	1276	2339904
Tricuspid valve incompetence	47.55	29.38	26	16879	1630	2339550
Blister	47.49	29.38	45	16860	6726	2334454
Cardiogenic shock	47.49	29.38	30	16875	2461	2338719
Interstitial lung disease	47.47	29.38	48	16857	7764	2333416
Pneumonia aspiration	47.38	29.38	35	16870	3707	2337473
Pallor	47.38	29.38	35	16870	3707	2337473
Head injury	47.23	29.38	36	16869	3998	2337182
Gait disturbance	47.22	29.38	82	16823	22463	2318717
Cardiometabolic syndrome	47.20	29.38	15	16890	229	2340951
Adjustment disorder	46.77	29.38	14	16891	173	2341007
Oedema	46.75	29.38	54	16851	10149	2331031
Aortic valve incompetence	46.40	29.38	21	16884	874	2340306
International normalised ratio increased	46.28	29.38	46	16859	7290	2333890
Proteinuria	46.19	29.38	31	16874	2819	2338361
Cerebral venous thrombosis	45.84	29.38	17	16888	421	2340759
Liver function test abnormal	45.47	29.38	46	16859	7444	2333736
Pyelonephritis acute	44.99	29.38	18	16887	550	2340630
Bezoar	44.98	29.38	14	16891	199	2340981
No adverse event	44.62	29.38	51	16854	9477	2331703
Feeling abnormal	44.56	29.38	82	16823	23499	2317681
Pre-eclampsia	44.26	29.38	24	16881	1480	2339700
Atrial septal defect	43.93	29.38	23	16882	1321	2339859
Latent autoimmune diabetes in adults	43.42	29.38	9	16896	18	2341162
Product dose omission	43.30	29.38	108	16797	38149	2303031
Fungal infection	43.18	29.38	37	16868	4852	2336328
Acid base balance abnormal	42.95	29.38	10	16895	41	2341139
Limb malformation	42.94	29.38	12	16893	114	2341066
Renal tubular disorder	42.91	29.38	17	16888	506	2340674
Adverse event	42.82	29.38	45	16860	7614	2333566
Acetonaemia	42.77	29.38	9	16896	20	2341160
Dermatitis exfoliative	42.75	29.38	22	16883	1219	2339961
Resuscitation	42.49	29.38	15	16890	321	2340859
Acute abdomen	42.49	29.38	15	16890	321	2340859
Bradypnoea	42.34	29.38	16	16889	418	2340762
Shock haemorrhagic	42.06	29.38	22	16883	1261	2339919
Liver injury	41.95	29.38	27	16878	2287	2338893
Congestive cardiomyopathy	41.86	29.38	20	16885	943	2340237
Foetal death	41.46	29.38	25	16880	1887	2339293
Congenital absence of bile ducts	41.34	29.38	8	16897	9	2341171
Cerebral haemorrhage	41.33	29.38	38	16867	5466	2335714
PO2 increased	41.20	29.38	12	16893	134	2341046
Diabetic neuropathy	41.17	29.38	16	16889	452	2340728
Obesity	41.04	29.38	23	16882	1513	2339667
Product use issue	40.69	29.38	55	16850	12114	2329066
Metastases to liver	40.63	29.38	29	16876	2912	2338268
Blood potassium decreased	40.57	29.38	37	16868	5268	2335912
Autoimmune haemolytic anaemia	40.54	29.38	18	16887	716	2340464
Hepatorenal syndrome	40.31	29.38	14	16891	285	2340895
Depression	40.14	29.38	87	16818	28045	2313135
Diabetic hyperosmolar coma	40.00	29.38	11	16894	98	2341082
Basilar artery thrombosis	39.67	29.38	9	16896	32	2341148
Cardiac failure congestive	39.66	29.38	63	16842	16038	2325142
Intestinal ischaemia	39.49	29.38	20	16885	1071	2340109
Pulmonary embolism	39.47	29.38	67	16838	18016	2323164
Psychomotor skills impaired	39.16	29.38	15	16890	407	2340773
Heart rate decreased	39.11	29.38	31	16874	3645	2337535
Prothrombin consumption time prolonged	38.95	29.38	7	16898	3	2341177
Thirst	38.95	29.38	23	16882	1671	2339509
HELLP syndrome	38.82	29.38	13	16892	236	2340944
Seizure	38.79	29.38	79	16826	24387	2316793
Blood magnesium decreased	38.78	29.38	21	16884	1291	2339889
Pemphigus	38.69	29.38	17	16888	659	2340521
Blood folate decreased	38.59	29.38	11	16894	113	2341067
Hepatitis cholestatic	38.38	29.38	20	16885	1137	2340043
Placental insufficiency	38.37	29.38	13	16892	245	2340935
Pulmonary hypoplasia	38.36	29.38	10	16895	71	2341109
Anal atresia	38.12	29.38	10	16895	73	2341107
Bundle branch block right	38.01	29.38	18	16887	832	2340348
Hyperphosphataemia	37.93	29.38	13	16892	254	2340926
Monoclonal B-cell lymphocytosis	37.68	29.38	7	16898	5	2341175
Urine albumin/creatinine ratio abnormal	37.68	29.38	7	16898	5	2341175
Impaired work ability	37.54	29.38	23	16882	1787	2339393
Atrioventricular block complete	37.31	29.38	21	16884	1393	2339787
Inappropriate antidiuretic hormone secretion	37.14	29.38	25	16880	2284	2338896
Bradykinesia	37.04	29.38	16	16889	595	2340585
Pancreatic atrophy	37.04	29.38	9	16896	46	2341134
Pancreatic failure	36.97	29.38	11	16894	133	2341047
Transient ischaemic attack	36.81	29.38	37	16868	5941	2335239
Skin turgor decreased	36.57	29.38	10	16895	87	2341093
Foetal hypokinesia	36.52	29.38	11	16894	139	2341041
Folate deficiency	36.46	29.38	12	16893	206	2340974
Pleural effusion	36.40	29.38	51	16854	11617	2329563
Acute hepatic failure	36.38	29.38	26	16879	2616	2338564
Hypoplastic left heart syndrome	35.83	29.38	9	16896	54	2341126
Ventricular fibrillation	35.81	29.38	24	16881	2177	2339003
Myopathy	35.61	29.38	21	16884	1522	2339658
Hyperglycaemic hyperosmolar nonketotic syndrome	35.60	29.38	10	16895	97	2341083
Hyperhomocysteinaemia	35.58	29.38	8	16897	27	2341153
Ventricular tachycardia	35.53	29.38	27	16878	2984	2338196
Aortitis	35.42	29.38	10	16895	99	2341081
Obstructive airways disorder	35.17	29.38	20	16885	1353	2339827
Pulse abnormal	35.16	29.38	13	16892	319	2340861
Gastritis	35.12	29.38	32	16873	4549	2336631
Insulin C-peptide decreased	34.84	29.38	7	16898	11	2341169
Urticarial vasculitis	34.76	29.38	9	16896	62	2341118
Liver disorder	34.64	29.38	37	16868	6377	2334803
Respiratory alkalosis	34.53	29.38	13	16892	336	2340844
Blood gases abnormal	34.47	29.38	10	16895	110	2341070
Sudden death	34.46	29.38	22	16883	1838	2339342
Abdominal tenderness	34.45	29.38	18	16887	1029	2340151
Bladder cancer	34.44	29.38	16	16889	708	2340472
Overweight	34.29	29.38	14	16891	451	2340729
Staphylococcal sepsis	34.16	29.38	18	16887	1047	2340133
Pyelonephritis	34.00	29.38	23	16882	2118	2339062
Temperature perception test abnormal	33.80	29.38	6	16899	2	2341178
Metabolic disorder	33.63	29.38	15	16890	603	2340577
Urine albumin/creatinine ratio increased	33.58	29.38	8	16897	37	2341143
Gamma-glutamyltransferase increased	33.47	29.38	34	16871	5528	2335652
Congenital aortic valve stenosis	33.44	29.38	7	16898	15	2341165
Hypoglycaemic unconsciousness	33.36	29.38	11	16894	190	2340990
Blood cholesterol increased	33.31	29.38	33	16872	5208	2335972
Transaminases increased	33.15	29.38	31	16874	4556	2336624
Hypokinesia	33.12	29.38	21	16884	1733	2339447
Platelet count increased	33.09	29.38	23	16882	2214	2338966
Foetal growth restriction	33.01	29.38	18	16887	1122	2340058
Shock hypoglycaemic	32.75	29.38	8	16897	42	2341138
Sputum discoloured	32.63	29.38	18	16887	1148	2340032
Neutrophilia	32.60	29.38	14	16891	513	2340667
Paraesthesia	32.30	29.38	69	16836	22019	2319161
Hyperinsulinaemia	32.28	29.38	8	16897	45	2341135
Rheumatic fever	32.16	29.38	9	16896	86	2341094
Pulmonary hypertension	32.11	29.38	32	16873	5086	2336094
Stool analysis abnormal	31.84	29.38	8	16897	48	2341132
Abdominal pain lower	31.77	29.38	25	16880	2908	2338272
Fallot's tetralogy	31.70	29.38	9	16896	91	2341089
Pain	31.65	29.38	133	16772	61724	2279456
Neonatal respiratory distress syndrome	31.59	29.38	14	16891	554	2340626
Cardiovascular insufficiency	31.52	29.38	12	16893	320	2340860
Hallucination, visual	31.43	29.38	25	16880	2954	2338226
Diabetic ulcer	31.43	29.38	8	16897	51	2341129
Cellulitis	31.39	29.38	42	16863	9159	2332021
Spine malformation	31.30	29.38	8	16897	52	2341128
Autoimmune hepatitis	31.28	29.38	20	16885	1675	2339505
Blindness	31.17	29.38	27	16878	3591	2337589
Carotid arteriosclerosis	31.09	29.38	10	16895	159	2341021
Brain injury	30.81	29.38	16	16889	903	2340277
Blood pressure systolic decreased	30.76	29.38	15	16890	740	2340440
Cardiopulmonary failure	30.56	29.38	15	16890	751	2340429
Acute coronary syndrome	30.08	29.38	19	16886	1558	2339622
Cyanosis	29.96	29.38	25	16880	3160	2338020
Renal disorder	29.90	29.38	29	16876	4459	2336721
Cardiovascular disorder	29.75	29.38	22	16883	2333	2338847
Haemofiltration	29.65	29.38	6	16899	10	2341170
Klebsiella infection	29.64	29.38	15	16890	802	2340378
Toxic encephalopathy	29.62	29.38	15	16890	803	2340377
Escherichia test positive	29.52	29.38	11	16894	276	2340904
Sleep apnoea syndrome	29.45	29.38	21	16884	2105	2339075

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Lactic acidosis	15604.12	33.80	3035	11708	2094	1729944
Acute kidney injury	7470.29	33.80	2479	12264	32465	1699573
Hypoglycaemia	3985.13	33.80	1114	13629	7324	1724714
Metabolic acidosis	3377.01	33.80	891	13852	4511	1727527
Completed suicide	2821.68	33.80	1001	13742	15311	1716727
Toxicity to various agents	2323.14	33.80	1021	13722	28120	1703918
Hyperkalaemia	2082.59	33.80	680	14063	7867	1724171
Diarrhoea	1576.91	33.80	963	13780	52889	1679149
Hypotension	1449.11	33.80	744	13999	28910	1703128
Renal failure	1395.28	33.80	641	14102	19376	1712662
Intentional overdose	1327.22	33.80	473	14270	7197	1724841
Blood glucose increased	1291.29	33.80	505	14238	10079	1721959
Vomiting	1128.71	33.80	690	14053	37625	1694413
Shock	901.77	33.80	304	14439	3857	1728181
Overdose	887.94	33.80	445	14298	16256	1715782
Diabetes mellitus inadequate control	839.18	33.80	238	14505	1604	1730434
Suicide attempt	735.42	33.80	305	14438	7076	1724962
Dehydration	670.09	33.80	376	14367	17282	1714756
Diabetic ketoacidosis	664.43	33.80	228	14515	3055	1728983
Abdominal pain	660.50	33.80	399	14344	21091	1710947
Hyperglycaemia	630.05	33.80	247	14496	4918	1727120
Glycosylated haemoglobin increased	622.44	33.80	190	14553	1701	1730337
Nausea	591.01	33.80	525	14218	50671	1681367
Blood lactic acid increased	580.79	33.80	153	14590	746	1731292
Haemodialysis	565.74	33.80	191	14552	2425	1729613
Anuria	550.94	33.80	173	14570	1715	1730323
Drug interaction	520.74	33.80	380	14363	27578	1704460
Pancreatitis acute	514.33	33.80	200	14543	3887	1728151
Hyperlactacidaemia	513.46	33.80	118	14625	278	1731760
Blood creatinine increased	506.96	33.80	289	14454	13657	1718381
Renal impairment	501.51	33.80	275	14468	12039	1719999
Coma	501.47	33.80	232	14511	7030	1725008
Hypoglycaemic coma	492.23	33.80	121	14622	419	1731619
Pancreatitis	466.47	33.80	220	14523	6967	1725071
Multiple organ dysfunction syndrome	456.99	33.80	235	14508	9007	1723031
Drug level increased	451.58	33.80	164	14579	2613	1729425
Confusional state	443.60	33.80	310	14433	20968	1711070
Cardiac arrest	413.32	33.80	266	14477	15664	1716374
Bradycardia	403.34	33.80	226	14517	10308	1721730
Dyspnoea	386.37	33.80	420	14323	51639	1680399
Diabetic metabolic decompensation	356.98	33.80	76	14667	104	1731934
Malaise	323.39	33.80	295	14448	29270	1702768
Cardio-respiratory arrest	317.04	33.80	185	14558	9108	1722930
Acidosis	314.41	33.80	107	14636	1390	1730648
Hypothermia	301.95	33.80	108	14635	1640	1730398
Weight decreased	296.70	33.80	251	14492	22502	1709536
Vitamin B12 deficiency	283.27	33.80	72	14671	295	1731743
Continuous haemodiafiltration	271.11	33.80	67	14676	238	1731800
Asthenia	267.47	33.80	286	14457	34384	1697654
Pancreatic carcinoma	258.35	33.80	96	14647	1633	1730405
Somnolence	254.44	33.80	202	14541	16537	1715501
Haemodynamic instability	251.42	33.80	88	14655	1249	1730789
Anion gap increased	243.68	33.80	60	14683	209	1731829
Drug hypersensitivity	241.54	33.80	188	14555	14947	1717091
Pemphigoid	240.90	33.80	82	14661	1065	1730973
Cardiogenic shock	239.12	33.80	100	14643	2354	1729684
Rhabdomyolysis	238.57	33.80	165	14578	10925	1721113
Hypertension	231.96	33.80	204	14539	19244	1712794
Blood glucose decreased	230.76	33.80	96	14647	2229	1729809
Respiratory failure	224.57	33.80	177	14566	14328	1717710
Poisoning	222.87	33.80	96	14647	2436	1729602
Decreased appetite	220.23	33.80	217	14526	23654	1708384
Diabetes mellitus	215.80	33.80	130	14613	6778	1725260
Sepsis	214.18	33.80	195	14548	19243	1712795
Exposure via ingestion	213.69	33.80	66	14677	614	1731424
Tachypnoea	209.50	33.80	90	14653	2268	1729770
Drug ineffective	208.17	33.80	345	14398	63456	1668582
Loss of consciousness	203.76	33.80	169	14574	14706	1717332
Foetal exposure during pregnancy	202.06	33.80	121	14622	6238	1725800
Blood glucose fluctuation	201.68	33.80	62	14681	567	1731471
Ketoacidosis	199.48	33.80	65	14678	730	1731308
Leukocytosis	198.23	33.80	98	14645	3435	1728603
Depressed level of consciousness	198.04	33.80	121	14622	6471	1725567
Syncope	196.19	33.80	162	14581	14007	1718031
Weight increased	194.08	33.80	147	14596	11210	1720828
Hepatotoxicity	189.40	33.80	91	14652	2993	1729045
Body temperature decreased	187.56	33.80	67	14676	1012	1731026
Diabetic neuropathy	187.36	33.80	56	14687	461	1731577
Haemolytic anaemia	185.16	33.80	77	14666	1785	1730253
Blood glucose abnormal	178.18	33.80	63	14680	922	1731116
Abdominal discomfort	174.12	33.80	126	14617	8955	1723083
Sopor	169.97	33.80	74	14669	1927	1730111
Dizziness	169.65	33.80	226	14517	34135	1697903
Renal tubular necrosis	169.11	33.80	75	14668	2044	1729994
Tachycardia	163.64	33.80	139	14604	12489	1719549
Anaemia	162.96	33.80	205	14538	29252	1702786
Hepatic steatosis	157.91	33.80	76	14667	2508	1729530
Medication error	157.82	33.80	93	14650	4650	1727388
Pancreatic carcinoma metastatic	157.61	33.80	51	14692	559	1731479
Atrial fibrillation	157.40	33.80	147	14596	14964	1717074
Jaundice	153.80	33.80	100	14643	5962	1726076
Agitation	152.41	33.80	126	14617	10900	1721138
Bladder cancer	152.05	33.80	69	14674	1987	1730051
Dialysis	147.79	33.80	71	14672	2333	1729705
Abdominal pain upper	144.36	33.80	122	14621	10879	1721159
Blood pH decreased	143.58	33.80	45	14698	441	1731597
Fatigue	142.20	33.80	257	14486	50524	1681514
Fall	137.28	33.80	181	14562	27033	1705005
Hypokalaemia	134.98	33.80	94	14649	6280	1725758
Cardiac failure	133.92	33.80	124	14619	12478	1719560
Hepatitis	133.74	33.80	85	14658	4870	1727168
Euglycaemic diabetic ketoacidosis	131.34	33.80	34	14709	152	1731886
Blood pressure increased	130.41	33.80	114	14629	10639	1721399
Unresponsive to stimuli	126.40	33.80	80	14663	4549	1727489
Drug-induced liver injury	125.12	33.80	70	14673	3167	1728871
Mental status changes	124.92	33.80	88	14655	5987	1726051
Pulmonary fibrosis	124.43	33.80	64	14679	2440	1729598
Poisoning deliberate	122.99	33.80	46	14697	796	1731242
Product residue present	122.37	33.80	45	14698	741	1731297
Lipase increased	121.65	33.80	55	14688	1569	1730469
Hypomagnesaemia	120.04	33.80	59	14684	2039	1729999
Blood bicarbonate decreased	120.02	33.80	38	14705	386	1731652
Anion gap	118.19	33.80	27	14716	61	1731977
Glomerular filtration rate decreased	117.63	33.80	52	14691	1405	1730633
Gastroenteritis	117.43	33.80	58	14685	2026	1730012
Inappropriate schedule of product administration	117.39	33.80	92	14651	7367	1724671
General physical health deterioration	116.58	33.80	117	14626	13001	1719037
Acute myocardial infarction	116.28	33.80	97	14646	8490	1723548
Hyponatraemia	112.31	33.80	97	14646	8903	1723135
Product prescribing error	112.31	33.80	59	14684	2351	1729687
Blood potassium increased	109.61	33.80	59	14684	2471	1729567
Chronic kidney disease	108.94	33.80	71	14672	4246	1727792
Sinus tachycardia	106.78	33.80	58	14685	2474	1729564
Accidental overdose	106.34	33.80	69	14674	4095	1727943
Lethargy	105.32	33.80	85	14658	7099	1724939
Respiratory distress	104.39	33.80	74	14669	5083	1726955
Diabetic nephropathy	104.32	33.80	32	14711	290	1731748
Hepatocellular injury	103.91	33.80	62	14681	3169	1728869
Blood lactic acid	103.69	33.80	20	14723	9	1732029
Coma scale abnormal	103.35	33.80	37	14706	562	1731476
Chest pain	102.73	33.80	134	14609	19780	1712258
Contraindicated product administered	102.16	33.80	47	14696	1397	1730641
Product complaint	102.13	33.80	56	14687	2434	1729604
Distributive shock	101.40	33.80	26	14717	111	1731927
Pruritus	101.24	33.80	144	14599	23078	1708960
Death	100.14	33.80	312	14431	87131	1644907
Pyrexia	99.48	33.80	210	14533	46190	1685848
Oliguria	97.49	33.80	43	14700	1155	1730883
Premature baby	96.03	33.80	57	14686	2885	1729153
Intentional product misuse	95.24	33.80	81	14662	7277	1724761
Condition aggravated	94.92	33.80	133	14610	21017	1711021
Disorientation	93.78	33.80	71	14672	5398	1726640
Myocardial infarction	93.61	33.80	151	14592	27023	1705015
Hyperventilation	92.22	33.80	34	14709	564	1731474
Diabetic foot infection	91.86	33.80	24	14719	112	1731926
Cholestasis	91.79	33.80	60	14683	3605	1728433
Thrombocytopenia	91.48	33.80	131	14612	21118	1710920
Encephalopathy	90.37	33.80	64	14679	4388	1727650
Ketonuria	88.75	33.80	24	14719	131	1731907
Acute respiratory distress syndrome	88.61	33.80	58	14685	3493	1728545
Blood pressure decreased	88.54	33.80	79	14664	7567	1724471
Arrhythmia	87.79	33.80	71	14672	5945	1726093
Polyuria	87.57	33.80	41	14702	1269	1730769
Adenocarcinoma pancreas	86.19	33.80	27	14716	264	1731774
Cardiopulmonary failure	86.11	33.80	36	14707	845	1731193
Hyperhidrosis	85.48	33.80	97	14646	12391	1719647
Alanine aminotransferase increased	85.11	33.80	96	14647	12182	1719856
Pulseless electrical activity	84.26	33.80	37	14706	983	1731055
Naevus flammeus	83.54	33.80	18	14725	27	1732011
Haematuria	83.38	33.80	76	14667	7484	1724554
Blood urea increased	82.63	33.80	62	14681	4649	1727389
Hepatic failure	82.63	33.80	68	14675	5835	1726203
Constipation	82.13	33.80	104	14639	14896	1717142
Myocardial ischaemia	81.74	33.80	53	14690	3140	1728898
Product administration error	80.51	33.80	51	14692	2902	1729136
Gamma-glutamyltransferase increased	80.44	33.80	63	14680	5035	1727003
Type 2 diabetes mellitus	79.13	33.80	43	14700	1835	1730203
Prerenal failure	78.94	33.80	25	14718	254	1731784
Back pain	78.30	33.80	107	14636	16506	1715532
Nephrolithiasis	77.83	33.80	56	14687	3936	1728102
Cardiovascular disorder	76.88	33.80	47	14696	2510	1729528
Pancreatitis chronic	76.59	33.80	25	14718	282	1731756
Coagulopathy	75.74	33.80	48	14695	2733	1729305
Hemiplegia	74.54	33.80	37	14706	1306	1730732
Blood pressure systolic increased	74.51	33.80	40	14703	1665	1730373
Hypovolaemia	74.31	33.80	36	14707	1204	1730834
Hepatitis acute	73.85	33.80	36	14707	1221	1730817
Hypocalcaemia	72.58	33.80	49	14694	3107	1728931
Metastases to liver	71.58	33.80	43	14700	2224	1729814
Atrioventricular block complete	71.35	33.80	37	14706	1434	1730604
Gastrointestinal disorder	71.32	33.80	57	14686	4691	1727347
Heart rate increased	70.92	33.80	65	14678	6445	1725593
Abdominal tenderness	70.38	33.80	28	14715	576	1731462
Acute lung injury	69.90	33.80	21	14722	176	1731862
Urosepsis	68.65	33.80	36	14707	1428	1730610
Altered state of consciousness	68.04	33.80	49	14694	3448	1728590
Myalgia	68.03	33.80	97	14646	15561	1716477
Septic shock	67.75	33.80	70	14673	8039	1723999
Ventricular tachycardia	66.64	33.80	50	14693	3748	1728290
Gait disturbance	66.44	33.80	86	14657	12584	1719454
Pneumonia aspiration	66.15	33.80	57	14686	5209	1726829
Interstitial lung disease	65.80	33.80	75	14668	9621	1722417
Blindness	65.71	33.80	44	14699	2752	1729286
Respiratory arrest	64.97	33.80	59	14684	5780	1726258
Vertigo	64.20	33.80	52	14691	4361	1727677
Dysarthria	64.19	33.80	56	14687	5203	1726835
Oedema peripheral	64.15	33.80	94	14649	15456	1716582
Product odour abnormal	64.09	33.80	21	14722	240	1731798
Respiratory rate increased	64.06	33.80	33	14710	1261	1730777
Circulatory collapse	63.87	33.80	47	14696	3420	1728618
Headache	63.83	33.80	147	14596	34229	1697809
Acetonaemia	62.74	33.80	13	14730	14	1732024
Treatment noncompliance	62.71	33.80	55	14688	5146	1726892
Latent autoimmune diabetes in adults	62.26	33.80	13	14730	15	1732023
Wrong product administered	61.57	33.80	31	14712	1128	1730910
Hypophagia	61.27	33.80	46	14697	3451	1728587
Aspartate aminotransferase increased	61.12	33.80	76	14667	10680	1721358
Nervous system disorder	61.01	33.80	40	14703	2414	1729624
Adverse drug reaction	60.97	33.80	52	14691	4686	1727352
Basilar artery thrombosis	60.87	33.80	14	14729	33	1732005
Pallor	60.05	33.80	45	14698	3366	1728672
Urinary tract infection	59.72	33.80	73	14670	10080	1721958
Metabolic disorder	59.69	33.80	24	14719	508	1731530
Muscle spasms	59.55	33.80	78	14665	11543	1720495
Diabetic retinopathy	58.59	33.80	21	14722	320	1731718
Polydipsia	58.54	33.80	26	14717	710	1731328
Foetal disorder	58.50	33.80	15	14728	64	1731974
Discomfort	58.41	33.80	40	14703	2596	1729442
Glycosuria	58.35	33.80	20	14723	265	1731773
Fournier's gangrene	58.29	33.80	18	14725	167	1731871
Renal aplasia	57.95	33.80	17	14726	130	1731908
Hepatitis cholestatic	57.75	33.80	31	14712	1290	1730748
Gastric ulcer	57.74	33.80	40	14703	2645	1729393
Cerebral ischaemia	57.25	33.80	29	14714	1069	1730969
Low birth weight baby	56.94	33.80	27	14716	860	1731178
Ventricular fibrillation	56.80	33.80	40	14703	2716	1729322
Vasoplegia syndrome	56.74	33.80	18	14725	184	1731854
Amylase increased	56.47	33.80	30	14713	1222	1730816
Urticaria	56.38	33.80	78	14665	12163	1719875
Neutropenia neonatal	55.56	33.80	13	14730	34	1732004
Diabetic ketoacidotic hyperglycaemic coma	55.29	33.80	13	14730	35	1732003
Obesity	54.81	33.80	28	14715	1051	1730987
Large for dates baby	54.47	33.80	16	14727	123	1731915
Neutrophilia	54.45	33.80	23	14720	554	1731484
Sinus bradycardia	54.23	33.80	34	14709	1899	1730139
Cholelithiasis	54.04	33.80	41	14702	3124	1728914
Hypovolaemic shock	53.32	33.80	26	14717	882	1731156
Urine albumin/creatinine ratio abnormal	52.93	33.80	10	14733	3	1732035
Cognitive disorder	52.62	33.80	46	14697	4284	1727754
Agranulocytosis	51.72	33.80	42	14701	3534	1728504
Incorrect dose administered	51.43	33.80	58	14685	7351	1724687
Ischaemic stroke	51.21	33.80	40	14703	3182	1728856
Product monitoring error	50.94	33.80	14	14729	82	1731956
Diabetic foetopathy	50.85	33.80	11	14732	17	1732021
Bundle branch block right	50.62	33.80	28	14715	1237	1730801
Transaminases increased	50.41	33.80	43	14700	3874	1728164
White blood cell count increased	50.35	33.80	57	14686	7255	1724783
Microalbuminuria	50.22	33.80	15	14728	123	1731915
Blood triglycerides increased	49.59	33.80	36	14707	2564	1729474
Superinfection	49.58	33.80	18	14725	285	1731753
Respiratory depression	49.56	33.80	34	14709	2213	1729825
Cough	49.52	33.80	94	14649	19103	1712935
Type I hypersensitivity	49.41	33.80	18	14725	288	1731750
Melaena	49.06	33.80	48	14695	5162	1726876
Toe amputation	48.90	33.80	20	14723	443	1731595
Aphasia	48.69	33.80	40	14703	3421	1728617
Rash	48.66	33.80	143	14600	38550	1693488
Antipsychotic drug level decreased	48.50	33.80	15	14728	140	1731898
Product substitution issue	48.38	33.80	39	14704	3247	1728791
Muscular weakness	48.23	33.80	66	14677	10183	1721855
PCO2 decreased	48.10	33.80	17	14726	248	1731790
Cerebrovascular accident	47.97	33.80	89	14654	17777	1714261
Flatulence	47.88	33.80	37	14706	2897	1729141
Anion gap abnormal	47.80	33.80	11	14732	26	1732012
Actinic elastosis	47.68	33.80	10	14733	12	1732026
Brain injury	47.34	33.80	25	14718	1006	1731032
Paraesthesia	47.23	33.80	66	14677	10385	1721653
Dysstasia	47.07	33.80	30	14713	1724	1730314
Drug level above therapeutic	47.03	33.80	20	14723	490	1731548
Bile duct stent insertion	46.84	33.80	12	14731	51	1731987
Drug intolerance	46.48	33.80	50	14693	6012	1726026
Presyncope	46.17	33.80	35	14708	2663	1729375
Pancreaticoduodenectomy	45.18	33.80	11	14732	36	1732002
Anaemia vitamin B12 deficiency	45.18	33.80	11	14732	36	1732002
Azotaemia	44.93	33.80	22	14721	753	1731285
Speech disorder	44.89	33.80	43	14700	4505	1727533
Blood sodium decreased	44.17	33.80	32	14711	2272	1729766
Dyspepsia	43.38	33.80	44	14699	4941	1727097
Vitamin B12 decreased	43.04	33.80	14	14729	156	1731882
Electrocardiogram QT prolonged	42.97	33.80	46	14697	5499	1726539
Toxic encephalopathy	42.83	33.80	21	14722	721	1731317
Hyperlipidaemia	42.82	33.80	31	14712	2198	1729840
Accidental exposure to product	42.81	33.80	40	14703	4061	1727977
Liver injury	42.74	33.80	29	14714	1853	1730185
Toxic skin eruption	42.73	33.80	29	14714	1854	1730184
Neuropathy peripheral	42.65	33.80	59	14684	9194	1722844
Genital infection fungal	42.55	33.80	13	14730	116	1731922
Erythema	42.32	33.80	74	14669	14114	1717924
Eosinophilia	41.92	33.80	37	14706	3490	1728548
Gastritis	41.72	33.80	35	14708	3082	1728956
Oesophageal perforation	41.41	33.80	13	14730	128	1731910
Intestinal ischaemia	41.29	33.80	23	14720	1030	1731008
Pneumonia	41.28	33.80	152	14591	46030	1686008
Product quality issue	41.10	33.80	47	14696	6046	1725992
Hyperoxaluria	40.78	33.80	10	14733	34	1732004
Dyslipidaemia	40.72	33.80	21	14722	804	1731234
Dysuria	40.63	33.80	37	14706	3635	1728403
Potentiating drug interaction	40.51	33.80	20	14723	697	1731341
Benign prostatic hyperplasia	40.25	33.80	25	14718	1373	1730665
Blood creatine phosphokinase increased	40.12	33.80	56	14687	8800	1723238
Rash erythematous	40.10	33.80	38	14705	3927	1728111
Intentional self-injury	39.94	33.80	32	14711	2641	1729397
Abnormal loss of weight	39.91	33.80	18	14725	510	1731528
Hypernatraemia	39.77	33.80	22	14721	972	1731066
Haemoglobin decreased	39.52	33.80	80	14663	17034	1715004
Base excess decreased	39.51	33.80	10	14733	40	1731998
Haemolysis	39.31	33.80	23	14720	1132	1730906
Hypoventilation	39.30	33.80	18	14725	529	1731509
Pollakiuria	39.26	33.80	33	14710	2913	1729125
Wernicke's encephalopathy	38.70	33.80	12	14731	113	1731925
Visual impairment	38.66	33.80	46	14697	6172	1725866
Renal injury	38.60	33.80	23	14720	1171	1730867
Fixed eruption	38.49	33.80	14	14729	223	1731815
Atrial septal defect	38.38	33.80	24	14719	1334	1730704
Cardiorenal syndrome	37.86	33.80	11	14732	81	1731957
Polyneuropathy	37.39	33.80	26	14717	1729	1730309
Blindness cortical	37.28	33.80	11	14732	86	1731952
Metastases to peritoneum	36.89	33.80	15	14728	327	1731711
Cerebral haematoma	36.88	33.80	19	14724	726	1731312
Palpitations	36.87	33.80	47	14696	6767	1725271
Gastrooesophageal reflux disease	36.80	33.80	39	14704	4608	1727430
Plasmapheresis	36.32	33.80	10	14733	59	1731979
Gout	36.31	33.80	30	14713	2586	1729452
Coordination abnormal	36.23	33.80	24	14719	1473	1730565
Polymerase chain reaction	36.01	33.80	8	14735	15	1732023
Diarrhoea haemorrhagic	35.81	33.80	21	14722	1038	1731000
Abdominal distension	35.74	33.80	45	14698	6399	1725639
Osteomyelitis	35.41	33.80	28	14715	2267	1729771
Pseudomonal sepsis	35.18	33.80	15	14728	370	1731668
Hypoperfusion	35.12	33.80	13	14730	218	1731820
Acute coronary syndrome	34.77	33.80	28	14715	2327	1729711
Hypoglycaemia neonatal	34.66	33.80	14	14729	300	1731738
Leukaemoid reaction	34.27	33.80	9	14734	43	1731995
Metastases to the mediastinum	34.27	33.80	9	14734	43	1731995
Proteinuria	34.12	33.80	30	14713	2814	1729224
Urine leukocyte esterase positive	34.10	33.80	9	14734	44	1731994
Aortic aneurysm	34.02	33.80	20	14723	993	1731045
Hepatic cirrhosis	33.88	33.80	29	14714	2624	1729414

Pharmacologic Action:

Source	Code	Description
ATC	A10BA02	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Biguanides
ATC	A10BD02	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD03	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD07	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD08	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD10	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD11	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD13	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD14	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD15	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD16	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD17	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD18	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD20	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD22	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD23	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD25	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
CHEBI has role	CHEBI:35526	hypoglycemic agent
FDA EPC	N0000175565	Biguanide
FDA CS	M0002471	Biguanides
MeSH PA	D007004	Hypoglycemic Agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Treatment Refractory Type 2 Diabetes Mellitus	indication
Gestational diabetes mellitus	off-label use	11687002	DOID:11714
Polycystic ovaries	off-label use	69878008
Weight loss	off-label use	89362005
Prevention of Type 2 Diabetes Mellitus	off-label use
Alcoholism	contraindication	7200002
Weight gain finding	contraindication	8943002
Asthenia	contraindication	13791008
Pulmonary edema	contraindication	19242006	DOID:11396
Myocardial infarction	contraindication	22298006	DOID:5844
Acute vomiting	contraindication	23971007
Severe adrenal insufficiency	contraindication	24867002
Alcohol intoxication	contraindication	25702006
Shock	contraindication	27942005
Dehydration	contraindication	34095006
Macular retinal edema	contraindication	37231002	DOID:4449
Infectious disease	contraindication	40733004
Body fluid retention	contraindication	43498006
End stage renal disease	contraindication	46177005	DOID:784
Chronic heart failure	contraindication	48447003
Lymphocytopenia	contraindication	48813009	DOID:614
Hepatic porphyria	contraindication	55056006	DOID:3133
Ketoacidosis	contraindication	56051008
Acute nephropathy	contraindication	58574008
Metabolic acidosis	contraindication	59455009
Hepatic failure	contraindication	59927004
Hemolytic anemia	contraindication	61261009	DOID:583
Glucose-6-phosphate dehydrogenase deficiency anemia	contraindication	62403005
Acute infectious disease	contraindication	63171007
Osteoporosis	contraindication	64859006	DOID:11476
Hypopituitarism	contraindication	74728003	DOID:9406
Cardiogenic shock	contraindication	89138009
Kidney disease	contraindication	90708001	DOID:557
Lactic acidosis	contraindication	91273001	DOID:3650
Fracture of bone	contraindication	125605004
Liver function tests abnormal	contraindication	166603001
Cobalamin deficiency	contraindication	190634004
Angina pectoris	contraindication	194828000
Decompensated cardiac failure	contraindication	195111005
Acute pancreatitis	contraindication	197456007	DOID:2913
Impaired renal function disorder	contraindication	197663003
Cerebrovascular accident	contraindication	230690007
Disease of liver	contraindication	235856003	DOID:409
Drug-induced hepatitis	contraindication	235876009
Hypoglycemic disorder	contraindication	237630007
Sepsis syndrome	contraindication	238150007
Edema	contraindication	267038008
Osteopenia	contraindication	312894000
Primary adrenocortical insufficiency	contraindication	373662000
Adrenal cortical hypofunction	contraindication	386584007	DOID:10493
Fever	contraindication	386661006
Surgical procedure	contraindication	387713003
Malignant tumor of urinary bladder	contraindication	399326009	DOID:11054
Severe diarrhea	contraindication	409587002
Breastfeeding (mother)	contraindication	413712001
Disorder of coronary artery	contraindication	414024009
Myocardial ischemia	contraindication	414795007	DOID:3393
Traumatic injury	contraindication	417746004
Fever greater than 100.4 Fahrenheit	contraindication	426000000
Radiography with IV Iodinated Contrast Agent	contraindication
Prolonged-Severe Nausea and Vomiting	contraindication
Severe Hypoxemia	contraindication
Severe Autonomic Insufficiency	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	12.63	Basic
pKa2	3.34	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	6414126	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6936590	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9198925	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6414126	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	6936590	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	9198925	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	6414126	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	6515117	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	6936590	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	9198925	Oct. 4, 2020	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FORTAMET	ANDRX LABS LLC	N021574	April 27, 2004	DISCN	TABLET, EXTENDED RELEASE	ORAL	6790459	March 17, 2021	METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FORTAMET	ANDRX LABS LLC	N021574	April 27, 2004	DISCN	TABLET, EXTENDED RELEASE	ORAL	6790459	March 17, 2021	METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
1GM	ACTOPLUS MET XR	TAKEDA PHARMS USA	N022024	May 12, 2009	DISCN	TABLET, EXTENDED RELEASE	ORAL	6790459	March 17, 2021	ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
1GM	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	6699871	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7125873	July 26, 2022	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE
1GM	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN IN COMBINATION WITH METFORMIN
500MG	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS APPROPRIATE
500MG	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	RE44186	July 31, 2023	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8119648	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8178541	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8119648	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8178541	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8119648	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8178541	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8119648	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8178541	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND, OPTIONALLY, A SULFONYLUREA
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8119648	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8178541	Aug. 12, 2023	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
500MG	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	8173663	March 15, 2025	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8222219	April 11, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8222219	April 11, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8222219	April 11, 2025	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-IV INHIBITOR
1GM	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
500MG	JANUMET XR	MERCK SHARP DOHME	N202270	Feb. 2, 2012	RX	TABLET, EXTENDED RELEASE	ORAL	7326708	Nov. 24, 2026	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8673927	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9173859	May 4, 2027	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	8501698	June 20, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	8513202	Dec. 3, 2027	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
500MG	KAZANO	TAKEDA PHARMS USA	N203414	Jan. 25, 2013	RX	TABLET	ORAL	7807689	June 27, 2028	METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
1GM	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	8414921	July 21, 2028	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
500MG	JANUMET	MERCK SHARP DOHME	N022044	March 30, 2007	RX	TABLET	ORAL	8414921	July 21, 2028	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF END STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	REDUCTION OF RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS IN THE TREATMENT OF TYPE 2 DIABETES MELLITUS PATIENTS
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	7943582	Feb. 26, 2029	TREATMENT OF TYPE 2 DIABETES MELLITUS
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	USE OF A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN AND A BASIC AMINO ACID TO TREAT TYPE 2 DIABETES MELLITUS
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10022379	April 2, 2029	METHOD OF TREATING TYPE 2 DIABETES USING A PHARMACEUTICAL COMPOSITION COMPRISING LINAGLIPTIN, METFORMIN, EMPAGLIFLOZIN AND A BASIC AMINO ACID
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	8551957	Oct. 14, 2029	METHOD OF TREATING TYPE 2 DIABETES MELLITUS USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
1GM	XIGDUO XR	ASTRAZENECA AB	N205649	July 28, 2017	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
500MG	XIGDUO XR	ASTRAZENECA AB	N205649	Oct. 29, 2014	RX	TABLET, EXTENDED RELEASE	ORAL	8685934	May 26, 2030	TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL (HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN, PIOGLITAZONE, OR ROSIGLITAZONE
1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	8846695	June 4, 2030	METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10406172	June 15, 2030	METHOD OF TREATING A TYPE 2 DIABETES MELLITUS PATIENT WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH METFORMIN USING A PHARMACEUTICAL COMPOSITION COMPRISING EMPAGLIFLOZIN, LINAGLIPTIN AND METFORMIN
1GM	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	8080580	July 13, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
500MG	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	8080580	July 13, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	9439902	Oct. 21, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
500MG	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	9439902	Oct. 21, 2030	AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WHO HAVE NOT BEEN PREVIOUSLY TREATED WITH AN ANTIHYPERGLYCEMIC AGENT BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9555001	March 6, 2033	METHOD OF TREATING TYPE 2 DIABETES IN PATIENTS WITH INSUFFICIENT GLYCEMIC CONTROL DESPITE THERAPY WITH ONE OR MORE CONVENTIONAL ANTIHYPERGLYCEMIC AGENTS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH METFORMIN
1GM	SYNJARDY	BOEHRINGER INGELHEIM	N206111	Aug. 26, 2015	RX	TABLET	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
500MG	SYNJARDY	BOEHRINGER INGELHEIM	N206111	Aug. 26, 2015	RX	TABLET	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	10258637	April 3, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN
1GM	SYNJARDY XR	BOEHRINGER INGELHEIM	N208658	Dec. 9, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN
1GM	TRIJARDY XR	BOEHRINGER INGELHEIM	N212614	Jan. 27, 2020	RX	TABLET, EXTENDED RELEASE	ORAL	9949998	June 11, 2034	METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT (45 ML/MIN/1.73 M2<=EGFR<60 ML/MIN/1.73 M2) BY ONCE DAILY ADMINISTRATION OF 10 MG OR 25 MG OF EMPAGLIFLOZIN IN COMBINATION WITH LINAGLIPTIN AND METFORMIN

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Feb. 1, 2020	NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Feb. 1, 2020	NEW CLINICAL DATA ADDED TO THE PRESCRIBING INFORMATION REGARDING CANAGLIFLOZIN ADD-ON COMBINATION THERAPY WITH METFORMIN AND A DIPEPTIDYL-PEPTIDASE-4 INHIBITOR
1GM	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	Feb. 27, 2020	PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
500MG	KOMBIGLYZE XR	ASTRAZENECA AB	N200678	Nov. 5, 2010	RX	TABLET, EXTENDED RELEASE	ORAL	Feb. 27, 2020	PACKAGE INSERT UPDATED WITH RESULTS FROM STUDY CV181168, A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, PHASE 3 TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF SAXAGLIPTIN ADDED TO DAPAGLIFLOZIN AND METFORMIN
1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANAGLIFLOZIN TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NONFATAL MYOCARDIAL INFARCTION AND NONFATAL STROKE) IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE (CVD)
1GM	QTERNMET XR	ASTRAZENECA AB	N210874	May 2, 2019	RX	TABLET, EXTENDED RELEASE	ORAL	May 2, 2022	NEW PRODUCT
1GM	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	Dec. 19, 2022	NEW CHEMICAL ENTITY
500MG	SEGLUROMET	MERCK SHARP DOHME	N209806	Dec. 19, 2017	RX	TABLET	ORAL	Dec. 19, 2022	NEW CHEMICAL ENTITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Mitochondrial complex I (NADH dehydrogenase)	Enzyme	O00217 O00483 O14561 O15239 O43181 O43674 O43676 O43677 O43678 O43920 O75251 O75306 O75380 O75438 O75489 O95139 O95167 O95168 O95169 O95178 O95182 O95298 O95299 O96000 P03886 P03891 P03897 P03901 P03905 P03915 P03923 P17568 P19404 P28331 P49821 P51970 P56181 P56556 Q16718 Q16795 Q86Y39 Q8N183 Q9BU61 Q9NRX3 Q9NX14 Q9P032 Q9P0J0 Q9UI09 Q9Y375 Q9Y6M9	ACPM_HUMAN CIA30_HUMAN MIMIT_HUMAN NDUA1_HUMAN NDUA2_HUMAN NDUA3_HUMAN NDUA4_HUMAN NDUA5_HUMAN NDUA6_HUMAN NDUA7_HUMAN NDUA8_HUMAN NDUA9_HUMAN NDUAA_HUMAN NDUAB_HUMAN NDUAC_HUMAN NDUAD_HUMAN NDUB1_HUMAN NDUB2_HUMAN NDUB3_HUMAN NDUB4_HUMAN NDUB5_HUMAN NDUB6_HUMAN NDUB7_HUMAN NDUB8_HUMAN NDUB9_HUMAN NDUBA_HUMAN NDUBB_HUMAN NDUC1_HUMAN NDUC2_HUMAN NDUF3_HUMAN NDUF4_HUMAN NDUS1_HUMAN NDUS2_HUMAN NDUS3_HUMAN NDUS4_HUMAN NDUS5_HUMAN NDUS6_HUMAN NDUS7_HUMAN NDUS8_HUMAN NDUV1_HUMAN NDUV2_HUMAN NDUV3_HUMAN NU1M_HUMAN NU2M_HUMAN NU3M_HUMAN NU4LM_HUMAN NU4M_HUMAN NU5M_HUMAN NU6M_HUMAN NUA4L_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN		IC50	4.54	CHEMBL
5'-AMP-activated protein kinase subunit beta-1	Kinase	Q9Y478	AAKB1_HUMAN				WOMBAT-PK
Solute carrier family 22 member 3	Transporter	O75751	S22A3_HUMAN		Km	2.50	WOMBAT-PK
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	3.40	WOMBAT-PK
Solute carrier family 22 member 1	Transporter	O15245	S22A1_HUMAN		IC50	2.70	WOMBAT-PK

External reference:

ID	Source
4023979	VUID
N0000021984	NUI
C0025598	UMLSCUI
D00944	KEGG_DRUG
786Z46389E	UNII
1115-70-4	SECONDARY_CAS_RN
109081006	SNOMEDCT_US
6809	RXNORM
372567009	SNOMEDCT_US
4023979	VANDF
004534	NDDF
d03807	MMSL
965	INN_ID
4091	PUBCHEM_CID
CHEBI:6801	CHEBI
CHEMBL1431	ChEMBL_ID
DB00331	DRUGBANK_ID
CHEMBL1703	ChEMBL_ID
MF8	PDB_CHEM_ID
D008687	MESH_DESCRIPTOR_UI
4779	IUPHAR_LIGAND_ID

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0078	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	19 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0080	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	19 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0081	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	19 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0575	TABLET, FILM COATED	500 mg	ORAL	NDA	19 sections
JANUMET	HUMAN PRESCRIPTION DRUG LABEL	2	0006-0577	TABLET, FILM COATED	1000 mg	ORAL	NDA	19 sections
SEGLUROMET	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5369	TABLET, FILM COATED	500 mg	ORAL	NDA	20 sections
SEGLUROMET	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5370	TABLET, FILM COATED	500 mg	ORAL	NDA	20 sections
SEGLUROMET	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5373	TABLET, FILM COATED	1000 mg	ORAL	NDA	20 sections
SEGLUROMET	HUMAN PRESCRIPTION DRUG LABEL	1	0006-5374	TABLET, FILM COATED	1000 mg	ORAL	NDA	20 sections
GLUCOPHAGE	HUMAN PRESCRIPTION DRUG LABEL	1	0087-6060	TABLET, FILM COATED	500 mg	ORAL	NDA	18 sections
GLUCOPHAGE	HUMAN PRESCRIPTION DRUG LABEL	1	0087-6063	TABLET, EXTENDED RELEASE	500 mg	ORAL	NDA	18 sections
GLUCOPHAGE	HUMAN PRESCRIPTION DRUG LABEL	1	0087-6064	TABLET, EXTENDED RELEASE	750 mg	ORAL	NDA	18 sections
GLUCOPHAGE	HUMAN PRESCRIPTION DRUG LABEL	1	0087-6070	TABLET, FILM COATED	850 mg	ORAL	NDA	18 sections
GLUCOPHAGE	HUMAN PRESCRIPTION DRUG LABEL	1	0087-6071	TABLET, FILM COATED	1000 mg	ORAL	NDA	18 sections
Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7212	TABLET, EXTENDED RELEASE	750 mg	ORAL	ANDA	13 sections
Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0093-7267	TABLET, EXTENDED RELEASE	500 mg	ORAL	ANDA	13 sections
Glipizide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7455	TABLET, FILM COATED	250 mg	ORAL	ANDA	13 sections
Glipizide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7456	TABLET, FILM COATED	500 mg	ORAL	ANDA	13 sections
Glipizide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0093-7457	TABLET, FILM COATED	500 mg	ORAL	ANDA	13 sections
metformin hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	0185-4416	TABLET, EXTENDED RELEASE	500 mg	ORAL	ANDA	18 sections
Glyburide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2751	TABLET, FILM COATED	250 mg	ORAL	ANDA	14 sections
Glyburide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2752	TABLET, FILM COATED	500 mg	ORAL	ANDA	14 sections
Glyburide and Metformin Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	2	0228-2753	TABLET, FILM COATED	500 mg	ORAL	ANDA	14 sections
KOMBIGLYZE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6125	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	18 sections
KOMBIGLYZE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6135	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	18 sections
KOMBIGLYZE	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6145	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	18 sections
XIGDUO	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6225	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	19 sections
XIGDUO	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6250	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	19 sections
XIGDUO	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6260	TABLET, FILM COATED, EXTENDED RELEASE	1000 mg	ORAL	NDA	19 sections
XIGDUO	HUMAN PRESCRIPTION DRUG LABEL	2	0310-6270	TABLET, FILM COATED, EXTENDED RELEASE	500 mg	ORAL	NDA	19 sections