empagliflozin indications/contra

Stem definitionDrug idCAS RN
sodium glucose co-transporter inhibitors, phlorizin derivatives 4830 864070-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • empagliflozin
  • BI 10773
  • jardiance
Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
  • Molecular weight: 450.91
  • Formula: C23H27ClO7
  • CLOGP: 2.59
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 108.61
  • ALOGS: -3.61
  • ROTB: 6

Drug dosage:

DoseUnitRoute
17.50 mg O

Approvals:

DateAgencyCompanyOrphan
Aug. 1, 2014 FDA BOEHRINGER INGELHEIM
March 20, 2014 EMA

FDA Adverse Event Reporting System

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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 2990.68 52.84 521 2557 4460 3378321
Ketoacidosis 1356.52 52.84 217 2861 962 3381819
Fungal infection 835.80 52.84 186 2892 5663 3377118
Dehydration 266.07 52.84 116 2962 33533 3349248
Pollakiuria 245.85 52.84 69 3009 5361 3377420
Urinary tract infection 241.07 52.84 106 2972 31222 3351559
Weight decreased 231.17 52.84 111 2967 40000 3342781
Blood ketone body increased 227.95 52.84 35 3043 107 3382674
Vomiting 207.41 52.84 136 2942 89395 3293386
Urine ketone body present 185.61 52.84 34 3044 362 3382419
Blood glucose increased 180.76 52.84 75 3003 19080 3363701
Glycosylated haemoglobin increased 159.14 52.84 43 3035 2889 3379892
Nausea 147.87 52.84 129 2949 129516 3253265
Ketonuria 144.60 52.84 25 3053 185 3382596
Dizziness 142.99 52.84 102 2976 76410 3306371
Metabolic acidosis 134.78 52.84 49 3029 8729 3374052
Pancreatitis 115.05 52.84 50 3028 14195 3368586
Glomerular filtration rate decreased 110.88 52.84 31 3047 2360 3380421
Rash 106.58 52.84 83 2995 70738 3312043
Vulvovaginal mycotic infection 101.96 52.84 23 3055 725 3382056
Urine ketone body 101.84 52.84 15 3063 31 3382750
Urosepsis 97.73 52.84 29 3049 2728 3380053
Acute kidney injury 96.63 52.84 68 3010 49615 3333166
Dysuria 92.95 52.84 34 3044 6148 3376633
Ketosis 84.12 52.84 15 3063 135 3382646
Polyuria 79.73 52.84 23 3055 1958 3380823
Blood creatinine increased 78.06 52.84 44 3034 21774 3361007
Cerebral infarction 76.44 52.84 32 3046 8268 3374513
Micturition urgency 75.24 52.84 21 3057 1586 3381195
Off label use 71.95 52.84 59 3019 53918 3328863

Pharmacologic Action:

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SourceCodeDescription
ATC A10BD19 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 A10BK03 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
CHEBI has role CHEBI:35526 hypoglycemic agent
FDA EPC N0000187059 Sodium-Glucose Cotransporter 2 Inhibitor
FDA MoA N0000187058 Sodium-Glucose Transporter 2 Inhibitors
MeSH PA D007004 Hypoglycemic Agents

Drug Use (View source of the data)

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DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Cardiovascular event reduce risk 405617006

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.62 acidic
pKa2 13.26 acidic
pKa3 13.7 acidic

Orange Book patent data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 6890898 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 7078381 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 7459428 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 6890898 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 7078381 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 7459428 Feb. 2, 2019 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8119648 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT INSULIN OR A SULFONYLUREA)
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8178541 Aug. 12, 2023 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN (WITH OR WITHOUT METFORMIN)
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8673927 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN AND METFORMIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 9173859 May 4, 2027 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL 8551957 Oct. 14, 2029 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN COMBINATION WITH EMPAGLIFLOZIN

Orange Book exclusivity data (new drug applications)

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Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Jan. 30, 2018 NEW COMBINATION
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Jan. 30, 2018 NEW COMBINATION
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 26, 2018 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND ACTIVE-CONTROLLED STUDY COMPARING EMPAGLIFLOZIN TO GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES AND INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN TREATMENT
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 26, 2018 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON A MULTIPLE DAILY INJECTION INSULIN REGIMEN ALONE OR WITH METFORMIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 26, 2018 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND ACTIVE-CONTROLLED STUDY COMPARING EMPAGLIFLOZIN TO GLIMEPIRIDE IN PATIENTS WITH TYPE 2 DIABETES AND INSUFFICIENT GLYCEMIC CONTROL DESPITE METFORMIN TREATMENT
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL June 26, 2018 UPDATED LABELING WITH DATA FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EMPAGLIFLOZIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND INSUFFICIENT GLYCEMIC CONTROL ON A MULTIPLE DAILY INJECTION INSULIN REGIMEN ALONE OR WITH METFORMIN
12.5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Aug. 26, 2018 NEW PRODUCT
5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Aug. 26, 2018 NEW PRODUCT
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL March 18, 2019 INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL March 18, 2019 INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
12.5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL March 18, 2019 INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL March 18, 2019 INFORMATION ADDED TO CLINICAL STUDIES SECTION OF THE LABELING REGARDING INITIAL COMBINATION THERAPY OF EMPAGLIFLOZIN WITH METFORMIN
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
12.5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
10MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
12.5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
25MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Aug. 1, 2019 NEW CHEMICAL ENTITY
10MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
25MG JARDIANCE BOEHRINGER INGELHEIM N204629 Aug. 1, 2014 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
10MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
25MG GLYXAMBI BOEHRINGER INGELHEIM N206073 Jan. 30, 2015 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
12.5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
5MG SYNJARDY BOEHRINGER INGELHEIM N206111 Aug. 26, 2015 RX TABLET ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
10MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
12.5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
25MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE
5MG SYNJARDY XR BOEHRINGER INGELHEIM N208658 Dec. 9, 2016 RX TABLET, EXTENDED RELEASE ORAL Dec. 2, 2019 TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED CARDIOVASCULAR DISEASE

Bioactivity Summary:

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TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium/glucose cotransporter 2 Transporter INHIBITOR Kd 7.24 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 1 Transporter IC50 5.08 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 4 Transporter IC50 4.96 SCIENTIFIC LITERATURE
Sodium/glucose cotransporter 5 Transporter IC50 5.96 SCIENTIFIC LITERATURE
Sodium/myo-inositol cotransporter 2 Transporter IC50 5.70 SCIENTIFIC LITERATURE

External reference:

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IDSource
CHEBI:82720 CHEBI
4754 IUPHAR_LIGAND_ID
D10459 KEGG_DRUG
4033569 VUID
N0000190927 NUI
C3490348 UMLSCUI
015572 NDDF
1545653 RXNORM
30461 MMSL
d08275 MMSL
4033569 VANDF
N0000190927 NDFRT
703894008 SNOMEDCT_US
703895009 SNOMEDCT_US
DB09038 DRUGBANK_ID
CHEMBL2107830 ChEMBL_ID
HDC1R2M35U UNII
9398 INN_ID
C570240 MESH_SUPPLEMENTAL_RECORD_UI
11949646 PUBCHEM_CID

Pharmaceutical products:

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ProductCategoryIngredientsNDCFormQuantityRoute MarketingLabel
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0152 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 0597-0153 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0159 TABLET 5 mg ORAL NDA 19 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0164 TABLET, FILM COATED 25 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0168 TABLET 12.50 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0175 TABLET 5 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0180 TABLET 12.50 mg ORAL NDA 19 sections
Glyxambi HUMAN PRESCRIPTION DRUG LABEL 2 0597-0182 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0280 TABLET, EXTENDED RELEASE 10 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0290 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0295 TABLET, EXTENDED RELEASE 25 mg ORAL NDA 19 sections
Synjardy HUMAN PRESCRIPTION DRUG LABEL 2 0597-0300 TABLET, EXTENDED RELEASE 12.50 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 55154-0411 TABLET, FILM COATED 10 mg ORAL NDA 19 sections
Jardiance HUMAN PRESCRIPTION DRUG LABEL 1 55154-0412 TABLET, FILM COATED 25 mg ORAL NDA 19 sections