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

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4758 842133-18-0

Description:

MoleculeDescription

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:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
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:

DateAgencyCompanyOrphan
March 29, 2013 FDA JANSSEN PHARMS
July 4, 2014 PMDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR IC50 8.66 WOMBAT-PK CHEMBL
Sodium/glucose cotransporter 1 Transporter IC50 5.72 CHEMBL
Protease Enzyme Ki 6.20 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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