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

Stem definition	Drug id	CAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives	4758	842133-18-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: invokana canagliflozin hemihydrate canagliflozin anhydrous canagliflozin canagliflozin hydrate	A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES. Molecular weight: 444.52 Formula: C24H25FO5S CLOGP: 4.55 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 90.15 ALOGS: -5 ROTB: 5 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

invokana
canagliflozin hemihydrate
canagliflozin anhydrous
canagliflozin
canagliflozin hydrate

A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.

Molecular weight: 444.52
Formula: C24H25FO5S
CLOGP: 4.55
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 90.15
ALOGS: -5
ROTB: 5

Status: ONP

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

Drug dosage:

Dose	Unit	Route
0.20	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.19 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	2.74 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	10.30 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
March 29, 2013	FDA	JANSSEN PHARMS
July 4, 2014	PMDA

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	3135.73	20.60	754	10800	17456	46657052
Fungal infection	2215.90	20.60	633	10921	28887	46645621
Genital infection fungal	775.65	20.60	114	11440	75	46674433
Ketoacidosis	502.37	20.60	129	11425	3826	46670682
Urinary tract infection	380.09	20.60	361	11193	219905	46454603
Euglycaemic diabetic ketoacidosis	316.82	20.60	78	11476	1938	46672570
Glycosylated haemoglobin increased	232.42	20.60	91	11463	10785	46663723
Toe amputation	218.25	20.60	58	11496	1966	46672542
Urine ketone body present	168.91	20.60	48	11506	2094	46672414
Vulvovaginal mycotic infection	162.54	20.60	55	11499	4296	46670212
Glomerular filtration rate decreased	146.59	20.60	67	11487	11627	46662881
Blood glucose increased	142.71	20.60	128	11426	71885	46602623
Weight decreased	121.85	20.60	200	11354	210649	46463859
Diabetic foot infection	119.62	20.60	23	11531	166	46674342
Pancreatitis	114.05	20.60	91	11463	43536	46630972
Urine output increased	103.14	20.60	29	11525	1216	46673292
Dehydration	101.20	20.60	158	11396	159382	46515126
Metabolic acidosis	99.46	20.60	80	11474	38700	46635808
Gangrene	99.25	20.60	39	11515	4656	46669852
Vulvovaginal pruritus	87.73	20.60	30	11524	2417	46672091
Pollakiuria	79.67	20.60	58	11496	24203	46650305
Pyelonephritis	65.19	20.60	43	11511	15314	46659194
Incorrect dose administered	63.82	20.60	67	11487	45483	46629025
Product use issue	63.07	20.60	96	11458	94548	46579960
Polyuria	59.39	20.60	31	11523	7164	46667344
Ketosis	57.80	20.60	15	11539	462	46674046
Osteomyelitis	56.98	20.60	46	11508	22337	46652171
Foot amputation	53.81	20.60	13	11541	297	46674211
Urosepsis	51.06	20.60	37	11517	15316	46659192
Leg amputation	50.24	20.60	19	11535	2044	46672464
Blood ketone body increased	49.93	20.60	12	11542	268	46674240
Treatment noncompliance	49.45	20.60	48	11506	29683	46644825
Adverse event	49.16	20.60	51	11503	34133	46640375
Acidosis	49.16	20.60	32	11522	11142	46663366
Vaginal infection	46.74	20.60	25	11529	6068	46668440
Diabetic foot	43.11	20.60	16	11538	1634	46672874
Off label use	41.00	20.60	194	11360	379647	46294861
Hypoglycaemia	37.40	20.60	56	11498	54293	46620215
Vulvovaginal candidiasis	35.95	20.60	16	11538	2605	46671903
Pruritus genital	35.69	20.60	11	11543	636	46673872
Dizziness	33.21	20.60	169	11385	340245	46334263
Blood glucose decreased	32.35	20.60	31	11523	18861	46655647
Rheumatoid arthritis	31.73	20.60	10	11544	240205	46434303
Limb amputation	31.38	20.60	5	11549	9	46674499
Anaemia	29.83	20.60	13	11541	255766	46418742
Amputation	29.14	20.60	7	11547	156	46674352
Ketonuria	27.44	20.60	8	11546	382	46674126
Rash	27.41	20.60	166	11388	356346	46318162
Acute kidney injury	27.23	20.60	123	11431	235732	46438776
Glucose urine present	27.09	20.60	9	11545	663	46673845
Thirst	26.75	20.60	22	11532	10954	46663554
Anion gap increased	26.72	20.60	11	11543	1480	46673028
Low density lipoprotein increased	25.94	20.60	17	11537	5983	46668525
Genital rash	25.74	20.60	8	11546	476	46674032
Micturition disorder	25.48	20.60	11	11543	1665	46672843
Haemorrhagic erosive gastritis	25.18	20.60	7	11547	281	46674227
Vulvovaginitis	24.76	20.60	7	11547	299	46674209
Type 2 diabetes mellitus	23.92	20.60	27	11527	19848	46654660
Necrotising fasciitis	23.66	20.60	12	11542	2611	46671897
Pain	23.60	20.60	52	11502	476896	46197612
Condition aggravated	23.41	20.60	16	11538	245036	46429472
Renal abscess	23.41	20.60	8	11546	643	46673865
Osteomyelitis acute	22.69	20.60	6	11548	199	46674309
Pyrexia	21.71	20.60	33	11521	348769	46325739
Creatinine renal clearance increased	21.53	20.60	7	11547	482	46674026
Thrombocytopenia	21.32	20.60	3	11551	126578	46547930

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
Diabetic ketoacidosis	2264.33	21.30	615	10464	15371	29926028
Toe amputation	689.31	21.30	161	10918	2080	29939319
Genital infection fungal	574.96	21.30	93	10986	99	29941300
Fungal infection	565.61	21.30	206	10873	13394	29928005
Diabetic foot infection	326.28	21.30	71	11008	647	29940752
Balanoposthitis	323.81	21.30	76	11003	1000	29940399
Osteomyelitis	298.55	21.30	133	10946	14548	29926851
Ketoacidosis	279.03	21.30	88	10991	3658	29937741
Euglycaemic diabetic ketoacidosis	272.67	21.30	74	11005	1797	29939602
Urine output increased	242.50	21.30	60	11019	998	29940401
Glycosylated haemoglobin increased	222.21	21.30	95	10984	9396	29932003
Glomerular filtration rate decreased	199.57	21.30	93	10986	11269	29930130
Gangrene	180.80	21.30	67	11012	4547	29936852
Foot amputation	166.55	21.30	38	11041	437	29940962
Pollakiuria	161.95	21.30	92	10987	16814	29924585
Weight decreased	157.18	21.30	233	10846	150688	29790711
Limb amputation	155.78	21.30	25	11054	24	29941375
Leg amputation	144.53	21.30	47	11032	2154	29939245
Urinary tract infection	135.51	21.30	151	10928	73508	29867891
Urine ketone body present	134.61	21.30	37	11042	942	29940457
Pancreatitis	132.60	21.30	109	10970	36381	29905018
Amputation	122.90	21.30	31	11048	559	29940840
Dehydration	120.28	21.30	185	10894	123354	29818045
Diabetic foot	119.17	21.30	43	11036	2702	29938697
Osteomyelitis acute	113.10	21.30	23	11056	145	29941254
Blood glucose increased	112.87	21.30	126	10953	61404	29879995
Skin ulcer	94.02	21.30	68	11011	18781	29922618
Metabolic acidosis	81.45	21.30	84	10995	37377	29904022
Ketonuria	74.65	21.30	21	11058	583	29940816
Lactic acidosis	64.27	21.30	68	11011	31145	29910254
Blood ketone body increased	60.16	21.30	16	11063	358	29941041
Ketosis	59.87	21.30	16	11063	365	29941034
Prostatitis	58.83	21.30	31	11048	4876	29936523
Glucose urine present	57.62	21.30	19	11060	909	29940490
Adverse event	56.01	21.30	46	11033	15295	29926104
Polyuria	52.32	21.30	33	11046	7273	29934126
Thirst	51.30	21.30	32	11047	6917	29934482
Cellulitis	46.67	21.30	71	11008	46713	29894686
Genital infection	45.80	21.30	8	11071	18	29941381
Incorrect dose administered	44.97	21.30	57	11022	31629	29909770
Dizziness	41.62	21.30	162	10917	194747	29746652
Cerebral infarction	41.54	21.30	50	11029	26323	29915076
Renal pain	41.15	21.30	20	11059	2652	29938747
Anaemia	39.26	21.30	14	11065	207978	29733421
Gas gangrene	38.86	21.30	8	11071	54	29941345
Treatment noncompliance	38.35	21.30	47	11032	25206	29916193
Hypoglycaemia	38.18	21.30	68	11011	50913	29890486
Product use issue	37.89	21.30	64	11015	45952	29895447
Acute kidney injury	37.11	21.30	199	10880	273643	29667756
Phimosis	35.28	21.30	12	11067	632	29940767
Blood creatinine increased	35.09	21.30	93	10986	91282	29850117
Thrombocytopenia	34.20	21.30	5	11074	137039	29804360
Diabetic ulcer	33.28	21.30	8	11071	117	29941282
Dysuria	32.69	21.30	41	11038	22500	29918899
Microalbuminuria	31.59	21.30	11	11068	622	29940777
Blood ketone body	31.56	21.30	7	11072	70	29941329
Osteomyelitis chronic	31.23	21.30	9	11070	273	29941126
Pyrexia	31.14	21.30	38	11041	294451	29646948
Death	31.02	21.30	53	11026	357230	29584169
Neuropathic arthropathy	30.93	21.30	8	11071	160	29941239
Hyperkalaemia	30.38	21.30	72	11007	65938	29875461
Acetonaemia	30.10	21.30	7	11072	88	29941311
Toxicity to various agents	30.05	21.30	14	11065	177169	29764230
Penile infection	29.90	21.30	6	11073	35	29941364
Genital rash	29.73	21.30	10	11069	509	29940890
Neutropenia	29.20	21.30	6	11073	128534	29812865
Glycosylated haemoglobin decreased	29.01	21.30	9	11070	353	29941046
Micturition disorder	28.96	21.30	14	11065	1835	29939564
Urinary tract infection fungal	28.51	21.30	9	11070	374	29941025
Diabetic gangrene	28.40	21.30	8	11071	223	29941176
Necrotising fasciitis	28.31	21.30	17	11062	3432	29937967
Therapeutic response increased	27.50	21.30	8	11071	251	29941148
Extremity necrosis	27.34	21.30	13	11066	1642	29939757
Nephrolithiasis	26.65	21.30	39	11040	24771	29916628
Drug interaction	26.55	21.30	21	11058	199547	29741852
Rash	24.27	21.30	137	10942	191752	29749647
Skin injury	23.32	21.30	10	11069	993	29940406
Urosepsis	23.17	21.30	24	11055	10708	29930691
Diabetes mellitus inadequate control	23.10	21.30	26	11053	12736	29928663
Pruritus genital	22.84	21.30	8	11071	460	29940939
Haemoglobin decreased	22.68	21.30	7	11072	114091	29827308
Urine ketone body	22.03	21.30	5	11074	56	29941343

Pharmacologic Action:

Source	Code	Description
ATC	A10BD16	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Combinations of oral blood glucose lowering drugs
ATC	A10BK02	ALIMENTARY TRACT AND METABOLISM DRUGS USED IN DIABETES BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS Sodium-glucose co-transporter 2 (SGLT2) inhibitors
MeSH PA	D007004	Hypoglycemic Agents
MeSH PA	D000077203	Sodium-Glucose Transporter 2 Inhibitors
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
FDA MoA	N0000187058	Sodium-Glucose Transporter 2 Inhibitors
FDA EPC	N0000187059	Sodium-Glucose Cotransporter 2 Inhibitor
CHEBI has role	CHEBI:35526	hypoglycemic drug
CHEBI has role	CHEBI:73273	sodium glucose co-transporter 2 inhibitor

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Diabetes mellitus type 2	indication	44054006	DOID:9352

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.62	acidic
pKa2	13.26	acidic
pKa3	13.7	acidic

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
100MG	INVOKANULL	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
300MG	INVOKANULL	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
150MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
150MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
50MG;1GM	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
50MG;500MG	INVOKAMET	JANSSEN PHARMS	N204353	Aug. 8, 2014	RX	TABLET	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
150MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
150MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
50MG;1GM	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
50MG;500MG	INVOKAMET XR	JANSSEN PHARMS	N205879	Sept. 20, 2016	RX	TABLET, EXTENDED RELEASE	ORAL	Oct. 29, 2021	NEW INDICATION FOR CANULLGLIFLOZIN 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)
100MG	INVOKANULL	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Sept. 27, 2022	TO REDUCE THE RISK OF END-STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND DIABETIC NEPHROPATHY WITH ALBUMINURIA > 300 MG/DAY
300MG	INVOKANULL	JANSSEN PHARMS	N204042	March 29, 2013	RX	TABLET	ORAL	Sept. 27, 2022	TO REDUCE THE RISK OF END-STAGE KIDNEY DISEASE, DOUBLING OF SERUM CREATININE, CARDIOVASCULAR DEATH, AND HOSPITALIZATION FOR HEART FAILURE IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND DIABETIC NEPHROPATHY WITH ALBUMINURIA > 300 MG/DAY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium/glucose cotransporter 2	Transporter	P31639	SC5A2_HUMAN	INHIBITOR	IC50	8.66	WOMBAT-PK	CHEMBL
Sodium/glucose cotransporter 1	Transporter	P13866	SC5A1_HUMAN		IC50	5.72	CHEMBL
Protease	Enzyme		Q9YQ12_9HIV1		Ki	6.20	CHEMBL

External reference:

ID	Source
D09592	KEGG_DRUG
928672-86-0	SECONDARY_CAS_RN
4032289	VANDF
C2974540	UMLSCUI
CHEBI:73272	CHEBI
CHEMBL2048484	ChEMBL_ID
CHEMBL4594217	ChEMBL_ID
CHEMBL2103841	ChEMBL_ID
DB08907	DRUGBANK_ID
D000068896	MESH_DESCRIPTOR_UI
9225	INN_ID
24812758	PUBCHEM_CID
4582	IUPHAR_LIGAND_ID
0SAC974Z85	UNII
1373458	RXNORM
200558	MMSL
29373	MMSL
d08080	MMSL
014959	NDDF
703676004	SNOMEDCT_US
703681008	SNOMEDCT_US
725664009	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4364	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5029	TABLET, FILM COATED	300 mg	ORAL	NDA	29 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5033	TABLET, FILM COATED	100 mg	ORAL	NDA	30 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50090-5034	TABLET, FILM COATED	100 mg	ORAL	NDA	29 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50458-140	TABLET, FILM COATED	100 mg	ORAL	NDA	30 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	50458-141	TABLET, FILM COATED	300 mg	ORAL	NDA	30 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-540	TABLET, FILM COATED	50 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-541	TABLET, FILM COATED	50 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-542	TABLET, FILM COATED	150 mg	ORAL	NDA	34 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	50458-543	TABLET, FILM COATED	150 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-940	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-941	TABLET, FILM COATED, EXTENDED RELEASE	50 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-942	TABLET, FILM COATED, EXTENDED RELEASE	150 mg	ORAL	NDA	34 sections
INVOKAMET XR	HUMAN PRESCRIPTION DRUG LABEL	2	50458-943	TABLET, FILM COATED, EXTENDED RELEASE	150 mg	ORAL	NDA	34 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	55154-1425	TABLET, FILM COATED	100 mg	ORAL	NDA	30 sections
INVOKANULL	HUMAN PRESCRIPTION DRUG LABEL	1	55154-1426	TABLET, FILM COATED	300 mg	ORAL	NDA	30 sections
INVOKAMET	HUMAN PRESCRIPTION DRUG LABEL	2	63629-8260	TABLET, FILM COATED	150 mg	ORAL	NDA	31 sections