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

Stem definition	Drug id	CAS RN
dipeptidyl aminopeptidase-IV inhibitors	4175	668270-12-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: linagliptin tradjenta BI 1356 BI-1356	Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output. Molecular weight: 472.55 Formula: C25H28N8O2 CLOGP: 1.91 LIPINSKI: 0 HAC: 10 HDO: 1 TPSA: 113.48 ALOGS: -3.97 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

linagliptin
tradjenta
BI 1356
BI-1356

Linagliptin is an inhibitor of DPP-4, an enzyme that degrades the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). Thus, linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin in a glucose-dependent manner and decreasing the levels of glucagon in the circulation. Both incretin hormones are involved in the physiological regulation of glucose homeostasis. Incretin hormones are secreted at a low basal level throughout the day and levels rise immediately after meal intake. GLP-1 and GIP increase insulin biosynthesis and secretion from pancreatic beta cells in the presence of normal and elevated blood glucose levels. Furthermore, GLP-1 also reduces glucagon secretion from pancreatic alpha cells, resulting in a reduction in hepatic glucose output.

Molecular weight: 472.55
Formula: C25H28N8O2
CLOGP: 1.91
LIPINSKI: 0
HAC: 10
HDO: 1
TPSA: 113.48
ALOGS: -3.97
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
5	mg	O

ADMET properties:

Property	Value	Reference
Vd (Volume of distribution)	16 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.90 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	129 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
May 2, 2011	FDA	BOEHRINGER INGELHEIM

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
Diabetic ketoacidosis	213.93	15.26	100	11567	18110	46656285
Pancreatitis	206.22	15.26	131	11536	43496	46630899
Pemphigoid	177.41	15.26	63	11604	5628	46668767
Hypoglycaemia	175.54	15.26	129	11538	54220	46620175
Blood glucose increased	172.06	15.26	143	11524	71870	46602525
Euglycaemic diabetic ketoacidosis	109.76	15.26	34	11633	1982	46672413
Glycosylated haemoglobin increased	95.52	15.26	49	11618	10827	46663568
Hyperglycaemia	80.23	15.26	68	11599	35003	46639392
Acute kidney injury	69.55	15.26	170	11497	235685	46438710
Renal impairment	67.63	15.26	88	11579	74284	46600111
Hyperlactacidaemia	59.59	15.26	22	11645	2193	46672202
Pancreatic carcinoma	58.89	15.26	30	11637	6527	46667868
Pancreatitis acute	58.47	15.26	49	11618	24823	46649572
Glomerular filtration rate decreased	54.87	15.26	35	11632	11659	46662736
Ketoacidosis	53.57	15.26	24	11643	3931	46670464
Lactic acidosis	52.72	15.26	53	11614	33856	46640539
Diabetic metabolic decompensation	48.14	15.26	16	11651	1169	46673226
Metabolic acidosis	45.13	15.26	52	11615	38728	46635667
Diabetes mellitus inadequate control	44.01	15.26	32	11635	13182	46661213
Hyperkalaemia	42.98	15.26	58	11609	50651	46623744
Blood glucose abnormal	41.69	15.26	24	11643	6648	46667747
Fungal infection	40.23	15.26	43	11624	29477	46644918
Rheumatoid arthritis	36.02	15.26	8	11659	240207	46434188
Dizziness	33.08	15.26	170	11497	340244	46334151
Renal failure	31.39	15.26	80	11587	113514	46560881
Subarachnoid haemorrhage	30.48	15.26	24	11643	11129	46663266
Chronic kidney disease	29.07	15.26	43	11624	40828	46633567
Pain	27.75	15.26	48	11619	476900	46197495
Cardiac failure	27.14	15.26	61	11606	79887	46594508
Shock	26.60	15.26	30	11637	21815	46652580
Blood glucose decreased	26.59	15.26	28	11639	18864	46655531
Hypoglycaemic encephalopathy	25.29	15.26	7	11660	274	46674121
Diabetes mellitus	25.16	15.26	45	11622	50020	46624375
Mucosal membrane hyperplasia	24.87	15.26	5	11662	46	46674349
Dermatitis bullous	24.30	15.26	18	11649	7625	46666770
Altered state of consciousness	23.36	15.26	29	11638	23319	46651076
Lethargy	23.20	15.26	44	11623	51127	46623268
Lipase increased	22.41	15.26	18	11649	8585	46665810
Pruritus	22.09	15.26	119	11548	242233	46432162
Urinary tract infection	21.33	15.26	110	11557	220156	46454239
Parathyroid hyperplasia	20.33	15.26	5	11662	122	46674273
Blood creatinine increased	20.25	15.26	53	11614	76350	46598045
Urine calcium/creatinine ratio increased	19.67	15.26	5	11662	140	46674255
Bite	18.91	15.26	6	11661	378	46674017
Vomiting	18.83	15.26	184	11483	452610	46221785
Insulin-like growth factor decreased	18.74	15.26	6	11661	389	46674006
Mesenteric vein thrombosis	17.86	15.26	7	11660	821	46673574
Albuminuria	17.59	15.26	5	11662	216	46674179
Food refusal	16.23	15.26	5	11662	286	46674109
Pancreatic enzymes increased	15.43	15.26	6	11661	689	46673706
Blood potassium increased	15.27	15.26	20	11647	16947	46657448

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
Pemphigoid	420.34	13.69	150	13552	7378	29931398
Pancreatitis	225.92	13.69	163	13539	36327	29902449
Hypoglycaemia	176.02	13.69	162	13540	50819	29887957
Diabetic ketoacidosis	146	13.69	91	13611	15895	29922881
Glycosylated haemoglobin increased	140.37	13.69	74	13628	9417	29929359
Blood glucose increased	134.75	13.69	153	13549	61377	29877399
Dermatitis bullous	88.56	13.69	47	13655	6057	29932719
Euglycaemic diabetic ketoacidosis	81.17	13.69	31	13671	1840	29936936
Blood mercury abnormal	67.97	13.69	16	13686	169	29938607
5-hydroxyindolacetic acid in urine increased	65.95	13.69	16	13686	194	29938582
Cerebral infarction	53.29	13.69	63	13639	26310	29912466
Pancreatic carcinoma	50.67	13.69	36	13666	7801	29930975
Pancreatitis acute	48.02	13.69	59	13643	25636	29913140
Mean platelet volume increased	46.81	13.69	14	13688	389	29938387
Ventricular hyperkinesia	44.85	13.69	12	13690	220	29938556
Mitral valve thickening	44.85	13.69	12	13690	220	29938556
Right atrial enlargement	43.77	13.69	12	13690	242	29938534
Hyperglycaemia	43.30	13.69	66	13636	35134	29903642
Low density lipoprotein decreased	41.64	13.69	16	13686	965	29937811
Acute kidney injury	41.14	13.69	239	13463	273603	29665173
Cardiac failure	40.62	13.69	106	13596	83312	29855464
Hypochromasia	40.21	13.69	12	13690	331	29938445
Ketoacidosis	38.46	13.69	23	13679	3723	29935053
Hepatic neoplasm	37.80	13.69	18	13684	1841	29936935
Left atrial enlargement	36.31	13.69	12	13690	465	29938311
Left ventricular enlargement	33.81	13.69	12	13690	578	29938198
Blood glucose abnormal	33.63	13.69	24	13678	5235	29933541
Necrotising oesophagitis	33.62	13.69	11	13691	413	29938363
Haematocrit increased	30.38	13.69	15	13687	1661	29937115
Pericardial haemorrhage	30.17	13.69	18	13684	2900	29935876
Renal impairment	28.51	13.69	94	13608	84090	29854686
Diabetes mellitus inadequate control	28.31	13.69	32	13670	12730	29926046
Completed suicide	27.41	13.69	6	13696	99486	29839290
Mucosal dryness	27.09	13.69	12	13690	1039	29937737
Drug abuse	27.01	13.69	3	13699	82069	29856707
Expired product administered	25.33	13.69	16	13686	2853	29935923
Neoplasm	24.61	13.69	18	13684	4078	29934698
Glomerular filtration rate decreased	24.37	13.69	28	13674	11334	29927442
Interstitial lung disease	23.85	13.69	71	13631	60126	29878650
Diabetes mellitus	23.29	13.69	56	13646	41809	29896967
Amylase increased	22.94	13.69	20	13682	5821	29932955
Hypervolaemia	22.86	13.69	13	13689	1916	29936860
Haemoglobin increased	22.71	13.69	15	13687	2887	29935889
Chronic kidney disease	22.55	13.69	52	13650	37786	29900990
Toxicity to various agents	22.35	13.69	29	13673	177154	29761622
Urine ketone body present	21.51	13.69	10	13692	969	29937807
Lipase increased	21.39	13.69	23	13679	8653	29930123
Left atrial dilatation	20.91	13.69	12	13690	1799	29936977
Diabetic nephropathy	20.56	13.69	12	13690	1857	29936919
Diabetic ketoacidotic hyperglycaemic coma	20.19	13.69	6	13696	163	29938613
Hypertensive heart disease	20.13	13.69	13	13689	2407	29936369
Red blood cell count decreased	20.09	13.69	40	13662	26281	29912495
Poikilocytosis	19.98	13.69	6	13696	169	29938607
Blood chloride increased	19.58	13.69	13	13689	2522	29936254
Genital infection fungal	19.43	13.69	6	13696	186	29938590
Haemodynamic instability	19.33	13.69	21	13681	7994	29930782
Hyperlactacidaemia	19.26	13.69	13	13689	2593	29936183
Blood phosphorus increased	19.23	13.69	13	13689	2598	29936178
Electrocardiogram T wave inversion	18.99	13.69	12	13690	2142	29936634
Hypohidrosis	18.85	13.69	6	13696	206	29938570
Neutropenia	18.40	13.69	19	13683	128521	29810255
Hypoglycaemic coma	18.12	13.69	12	13690	2319	29936457
Lactic acidosis	17.62	13.69	42	13660	31171	29907605
Bronchitis viral	17.60	13.69	6	13696	256	29938520
Blindness transient	17.48	13.69	11	13691	1948	29936828
Eosinophil count increased	17.02	13.69	19	13683	7454	29931322
High density lipoprotein decreased	16.82	13.69	13	13689	3197	29935579
Blood uric acid increased	16.70	13.69	17	13685	6006	29932770
Drug ineffective	16.53	13.69	90	13612	340297	29598479
Marasmus	16.51	13.69	7	13695	545	29938231
Hypovolaemia	16.46	13.69	20	13682	8585	29930191
Peak expiratory flow rate decreased	16.45	13.69	5	13697	147	29938629
Left ventricular dysfunction	16.30	13.69	20	13682	8671	29930105
Hepatic function abnormal	16.16	13.69	49	13653	41896	29896880
Immune-mediated myositis	16.15	13.69	9	13693	1276	29937500
Skin disorder	16.04	13.69	23	13679	11585	29927191
Urticaria	15.88	13.69	58	13644	54548	29884228
Gastric cancer	15.63	13.69	15	13687	4935	29933841
Femoral neck fracture	15.61	13.69	12	13690	2930	29935846
Rhinalgia	15.14	13.69	6	13696	393	29938383
Electrocardiogram ST segment elevation	15.06	13.69	14	13688	4428	29934348
Drug eruption	15.05	13.69	28	13674	17498	29921278
Dust allergy	14.88	13.69	6	13696	411	29938365
Erythema multiforme	14.37	13.69	18	13684	7967	29930809
Nephrogenic anaemia	14.23	13.69	10	13692	2129	29936647
Blood iron decreased	14.21	13.69	13	13689	4027	29934749
Red cell distribution width increased	14.07	13.69	13	13689	4081	29934695
Haematocrit decreased	13.89	13.69	38	13664	30661	29908115
Aortic valve incompetence	13.84	13.69	14	13688	4909	29933867

Pharmacologic Action:

Source	Code	Description
ATC	A10BD11	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BD19	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BH05	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Dipeptidyl peptidase 4 (DPP-4) inhibitors
MeSH PA	D054873	Dipeptidyl-Peptidase IV Inhibitors
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006728	Hormones
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D054795	Incretins
MeSH PA	D011480	Protease Inhibitors
FDA MoA	N0000175912	Dipeptidyl Peptidase 4 Inhibitors
FDA EPC	N0000175913	Dipeptidyl Peptidase 4 Inhibitor
CHEBI has role	CHEBI:35526	hypoglycemic drug
CHEBI has role	CHEBI:68612	dpp-4 inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352
Pancreatitis	contraindication	75694006	DOID:4989
Hypoglycemic disorder	contraindication	237630007

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.16	Basic
pKa2	6.13	Basic
pKa3	3.79	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	July 3, 2022	INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINULL TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4
5MG	TRADJENTA	BOEHRINGER INGELHEIM	N201280	May 2, 2011	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;500MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;850MG	JENTADUETO	BOEHRINGER INGELHEIM	N201281	Jan. 30, 2012	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
10MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
25MG;5MG	GLYXAMBI	BOEHRINGER INGELHEIM	N206073	Jan. 30, 2015	RX	TABLET	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
2.5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME
5MG;1GM	JENTADUETO XR	BOEHRINGER INGELHEIM	N208026	May 27, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	March 30, 2023	ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Dipeptidyl peptidase 4	Enzyme	P27487	DPP4_HUMAN	INHIBITOR	IC50	10	CHEMBL	CHEMBL
Prolyl endopeptidase FAP	Enzyme	Q12884	SEPR_HUMAN		IC50	7.05	CHEMBL
Muscarinic acetylcholine receptor M1	GPCR	P11229	ACM1_HUMAN		IC50	6.53	CHEMBL
Dipeptidyl peptidase 9	Enzyme	Q86TI2	DPP9_HUMAN		IC50	4	CHEMBL
Prolyl endopeptidase FAP	Enzyme		SEPR_MOUSE		IC50	6.43	CHEMBL

External reference:

ID	Source
4030725	VUID
N0000182735	NUI
D09566	KEGG_DRUG
4030725	VANDF
C2352547	UMLSCUI
CHEBI:68610	CHEBI
356	PDB_CHEM_ID
CHEMBL237500	ChEMBL_ID
D000069476	MESH_DESCRIPTOR_UI
DB08882	DRUGBANK_ID
10096344	PUBCHEM_CID
6318	IUPHAR_LIGAND_ID
9039	INN_ID
3X29ZEJ4R2	UNII
1100699	RXNORM
181237	MMSL
27861	MMSL
d07767	MMSL
013732	NDDF
702798009	SNOMEDCT_US
703667006	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0140	TABLET, FILM COATED	5 mg	ORAL	NDA	29 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0146	TABLET, FILM COATED	2.50 mg	ORAL	NDA	32 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0147	TABLET, FILM COATED	2.50 mg	ORAL	NDA	32 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0148	TABLET, FILM COATED	2.50 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0164	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Glyxambi	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0182	TABLET, FILM COATED	5 mg	ORAL	NDA	32 sections
Jentadueto XR	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0270	TABLET, FILM COATED, EXTENDED RELEASE	2.50 mg	ORAL	NDA	32 sections
Jentadueto XR	HUMAN PRESCRIPTION DRUG LABEL	2	0597-0275	TABLET, FILM COATED, EXTENDED RELEASE	5 mg	ORAL	NDA	32 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0380	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0385	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0390	TABLET, EXTENDED RELEASE	5 mg	ORAL	NDA	34 sections
Trijardy XR	HUMAN PRESCRIPTION DRUG LABEL	3	0597-0395	TABLET, EXTENDED RELEASE	2.50 mg	ORAL	NDA	34 sections
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4383	TABLET, FILM COATED	5 mg	ORAL	NDA	29 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	54868-6461	TABLET, FILM COATED	2.50 mg	ORAL	NDA	28 sections
Tradjenta	HUMAN PRESCRIPTION DRUG LABEL	1	55154-0410	TABLET, FILM COATED	5 mg	ORAL	NDA	29 sections
Jentadueto	HUMAN PRESCRIPTION DRUG LABEL	2	63629-6524	TABLET, FILM COATED	2.50 mg	ORAL	NDA	31 sections