saxagliptin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
dipeptidyl aminopeptidase-IV inhibitors 4114 361442-04-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • saxagliptin
  • onglyza
  • saxagliptin hydrochloride
  • saxagliptin hydrate
  • saxagliptin HCl
  • BMS-477118
  • BMS 477118
inhibits Dipeptidyl Peptidase-4
  • Molecular weight: 315.42
  • Formula: C18H25N3O2
  • CLOGP: 0.25
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 90.35
  • ALOGS: -2.14
  • ROTB: 2

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
5 mg O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.23 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
S (Water solubility) 17.60 mg/mL Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 24 % Hosey CM, Chan R, Benet LZ
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 7.10 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
July 31, 2009 FDA ASTRAZENECA AB

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
Pancreatitis 80.19 19.47 47 3980 42567 50558530
Blood glucose increased 51.97 19.47 44 3983 71280 50529817
Acute lymphocytic leukaemia 34.54 19.47 11 4016 2230 50598867
Hypoglycaemia 32.88 19.47 30 3997 53551 50547546
Acute kidney injury 32.56 19.47 62 3965 227996 50373101
Lactic acidosis 31.56 19.47 24 4003 33331 50567766
Pancreatitis acute 29.07 19.47 20 4007 23792 50577305
Urinary tract obstruction 28.68 19.47 9 4018 1739 50599358
Oedema peripheral 27.70 19.47 47 3980 157914 50443183
Diabetic ketoacidosis 24.18 19.47 16 4011 17856 50583241
Dehydration 23.66 19.47 43 3984 152406 50448691
Nausea 23.32 19.47 114 3913 705284 49895813
Abdominal pain 23.01 19.47 55 3972 236173 50364924
Ketoacidosis 21.64 19.47 9 4018 3886 50597211
Angioedema 20.99 19.47 20 4007 37656 50563441
Diarrhoea 20.05 19.47 96 3931 588380 50012717

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
Pancreatitis 84.96 18.52 57 4401 34457 29535612
Pancreatic carcinoma 84.55 18.52 34 4424 7116 29562953
Hypoglycaemia 42.55 18.52 44 4414 48302 29521767
Insulin C-peptide decreased 40.71 18.52 7 4451 44 29570025
Diabetic ketoacidotic hyperglycaemic coma 38.67 18.52 8 4450 148 29569921
Pancreatitis acute 36.74 18.52 30 4428 24355 29545714
Vertigo 35.28 18.52 28 4430 21833 29548236
Blood glucose increased 33.80 18.52 43 4415 58941 29511128
Hypoglycaemic coma 31.61 18.52 12 4446 2151 29567918
Diabetes mellitus inadequate control 29.71 18.52 20 4438 12114 29557955
Glycosylated haemoglobin increased 26.64 18.52 17 4441 9409 29560660
Dizziness 24.24 18.52 73 4385 189611 29380458
Acute kidney injury 24.11 18.52 91 4367 265176 29304893
Post procedural erythema 23.40 18.52 3 4455 0 29570069
Spleen congestion 23.20 18.52 6 4452 303 29569766
Suprapubic pain 22.46 18.52 6 4452 344 29569725
Dyspepsia 22.23 18.52 25 4433 30100 29539969
Medullary thyroid cancer 22.10 18.52 4 4454 35 29570034
Abdominal pain upper 19.73 18.52 34 4424 60959 29509110
Abnormal loss of weight 19.60 18.52 10 4448 3624 29566445
Ketoacidosis 19.59 18.52 10 4448 3629 29566440

FDA Adverse Event Reporting System (Geriatric)

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
Pancreatitis 136.39 16.42 85 7321 59522 64431804
Pancreatic carcinoma 77.87 16.42 33 7373 10340 64480986
Pancreatitis acute 61.85 16.42 46 7360 42809 64448517
Blood glucose increased 60.40 16.42 65 7341 98008 64393318
Hypoglycaemia 57.87 16.42 61 7345 89831 64401495
Acute kidney injury 48.90 16.42 137 7269 449103 64042223
Ketoacidosis 42.28 16.42 19 7387 6844 64484482
Insulin C-peptide decreased 39.82 16.42 7 7399 69 64491257
Diabetic ketoacidotic hyperglycaemic coma 37.91 16.42 8 7398 217 64491109
Hypoglycaemic coma 36.80 16.42 15 7391 4259 64487067
Lactic acidosis 36.55 16.42 40 7366 61370 64429956
Diabetes mellitus inadequate control 35.57 16.42 25 7381 21296 64470030
Acute lymphocytic leukaemia 29.82 16.42 13 7393 4358 64486968
Dehydration 28.46 16.42 71 7335 216692 64274634
Glycosylated haemoglobin increased 27.23 16.42 19 7387 16000 64475326
Cerebral infarction 26.64 16.42 28 7378 41016 64450310
Diabetic ketoacidosis 26.17 16.42 24 7382 29821 64461505
Cardiac failure 26.03 16.42 51 7355 132322 64359004
Post procedural erythema 24.22 16.42 3 7403 0 64491326
Angioedema 23.33 16.42 32 7374 61789 64429537
Spleen congestion 22.69 16.42 6 7400 436 64490890
Dyspepsia 22.30 16.42 36 7370 80276 64411050
Pemphigoid 21.13 16.42 15 7391 12971 64478355
Vertigo 19.97 16.42 29 7377 58982 64432344
Nausea 19.94 16.42 156 7250 785644 63705682
Urosepsis 19.82 16.42 18 7388 22076 64469250
Suprapubic pain 18.59 16.42 6 7400 876 64490450
Medullary thyroid cancer 17.84 16.42 4 7402 145 64491181
Angina pectoris 16.50 16.42 23 7383 45058 64446268
Hyperglycaemia 16.47 16.42 27 7379 60941 64430385

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A10BD10 ALIMENTARY TRACT AND METABOLISM
DRUGS USED IN DIABETES
BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
Combinations of oral blood glucose lowering drugs
ATC A10BD21 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
ATC A10BH03 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
CHEBI has role CHEBI:35526 antidiabetic
CHEBI has role CHEBI:68612 dipeptidyl peptidase-4 inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Diabetes mellitus type 2 indication 44054006 DOID:9352
Alcoholism contraindication 7200002
Asthenia contraindication 13791008
Myocardial infarction contraindication 22298006 DOID:5844
Acute vomiting contraindication 23971007
Alcohol intoxication contraindication 25702006
Shock contraindication 27942005
Dehydration contraindication 34095006
Infectious disease contraindication 40733004
End stage renal disease contraindication 46177005 DOID:784
Lymphocytopenia contraindication 48813009 DOID:614
Ketoacidosis contraindication 56051008
Acute nephropathy contraindication 58574008
Metabolic acidosis contraindication 59455009
Hypopituitarism contraindication 74728003 DOID:9406
Cardiogenic shock contraindication 89138009
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Cobalamin deficiency contraindication 190634004
Decompensated cardiac failure contraindication 195111005
Disease of liver contraindication 235856003 DOID:409
Hypoglycemic disorder contraindication 237630007
Sepsis syndrome contraindication 238150007
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Fever contraindication 386661006
Surgical procedure contraindication 387713003
Severe diarrhea contraindication 409587002
Traumatic injury contraindication 417746004
Radiography with IV Iodinated Contrast Agent contraindication
Severe Hypoxemia contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.77 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 2.5MG BASE ONGLYZA ASTRAZENECA AB N022350 July 31, 2009 RX TABLET ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
EQ 2.5MG BASE ONGLYZA ASTRAZENECA AB N022350 July 31, 2009 RX TABLET ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA
EQ 5MG BASE ONGLYZA ASTRAZENECA AB N022350 July 31, 2009 RX TABLET ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
EQ 5MG BASE ONGLYZA ASTRAZENECA AB N022350 July 31, 2009 RX TABLET ORAL RE44186 July 31, 2023 METHOD FOR TREATING TYPE II DIABETES MELLITUS BY ADMINISTERING SAXAGLIPTIN ALONE OR IN COMBINATION WITH INSULIN, METFORMIN, A THIAZOLIDINEDIONE, GLYBURIDE OR METFORMIN PLUS A SULFONYLUREA
1GM;EQ 2.5MG BASE 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;EQ 2.5MG BASE 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;EQ 5MG BASE 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;EQ 5MG BASE 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;EQ 5MG BASE 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;EQ 5MG BASE 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
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 May 2, 2019 RX TABLET ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL RE44186 July 31, 2023 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 May 2, 2019 RX TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8501698 June 20, 2027 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8501698 June 20, 2027 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 May 2, 2019 RX TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8361972 March 21, 2028 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO ARE ALREADY TREATED WITH DAPAGLIFLOZIN AND SAXAGLIPTIN
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8361972 March 21, 2028 METHOD FOR TREATING TYPE 2 DIABETES MELLITUS (T2DM) IN PATIENTS WHO HAVE INADEQUATE CONTROL WITH DAPAGLIFLOZIN
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 May 2, 2019 RX TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 RX TABLET ORAL May 2, 2022 EXPANDED INDICATION FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE QTERN ASTRAZENECA AB N209091 May 2, 2019 RX TABLET ORAL May 2, 2022 NEW STRENGTH
10MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL May 2, 2022 NEW PRODUCT
2.5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL May 2, 2022 NEW PRODUCT
5MG;1GM;EQ 2.5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL May 2, 2022 NEW PRODUCT
5MG;1GM;EQ 5MG BASE QTERNMET XR ASTRAZENECA AB N210874 May 2, 2019 DISCN TABLET, EXTENDED RELEASE ORAL May 2, 2022 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dipeptidyl peptidase 4 Enzyme INHIBITOR Ki 9.22 CHEMBL CHEMBL
Cytochrome P450 3A4 Enzyme WOMBAT-PK
Multidrug resistance protein 1 Transporter WOMBAT-PK
Dipeptidyl peptidase 8 Enzyme Ki 6.89 CHEMBL
Dipeptidyl peptidase 9 Enzyme Ki 7.15 CHEMBL

External reference:

IDSource
4029055 VUID
N0000179814 NUI
D08996 KEGG_DRUG
709031-78-7 SECONDARY_CAS_RN
4029055 VANDF
4029067 VANDF
C1611934 UMLSCUI
CHEBI:71272 CHEBI
CHEMBL385517 ChEMBL_ID
CHEMBL2103745 ChEMBL_ID
CHEMBL1201743 ChEMBL_ID
DB06335 DRUGBANK_ID
C502994 MESH_SUPPLEMENTAL_RECORD_UI
11243969 PUBCHEM_CID
6316 IUPHAR_LIGAND_ID
9GB927LAJW UNII
1043560 RXNORM
166611 MMSL
26648 MMSL
32427 MMSL
d07467 MMSL
013204 NDDF
013205 NDDF
443066009 SNOMEDCT_US
443087004 SNOMEDCT_US
734452007 SNOMEDCT_US
BJM PDB_CHEM_ID
945667-22-1 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ONGLYZA HUMAN PRESCRIPTION DRUG LABEL 1 0310-6100 TABLET, FILM COATED 2.50 mg ORAL NDA 30 sections
ONGLYZA HUMAN PRESCRIPTION DRUG LABEL 1 0310-6105 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
KOMBIGLYZEXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6125 TABLET, FILM COATED, EXTENDED RELEASE 2.50 mg ORAL NDA 30 sections
KOMBIGLYZEXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6135 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL NDA 30 sections
KOMBIGLYZEXR HUMAN PRESCRIPTION DRUG LABEL 2 0310-6145 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL NDA 30 sections
QTERN HUMAN PRESCRIPTION DRUG LABEL 2 0310-6770 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
QTERN HUMAN PRESCRIPTION DRUG LABEL 2 0310-6770 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
QTERN HUMAN PRESCRIPTION DRUG LABEL 2 0310-6780 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
QTERN HUMAN PRESCRIPTION DRUG LABEL 2 0310-6780 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
ONGLYZA HUMAN PRESCRIPTION DRUG LABEL 1 54868-6309 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
ONGLYZA HUMAN PRESCRIPTION DRUG LABEL 1 55154-6931 TABLET, FILM COATED 5 mg ORAL NDA 30 sections