saxagliptin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: OFP

  • 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) 63 mg/mL Bocci G, Oprea TI, 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
BA (Bioavailability) 0.87 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.002 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.873 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 3.357 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.581 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 80.940 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 80.650 % High 1
herg hERG pIC50 4.230 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.119 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.155 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 87.190 % High 1
kinase-safety-class CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4 6
kinase-selectivity-class PDK1 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.328 High 1
mh-clint Mouse hepatocyte intrinsic clearance 5.702 High 1
mppb Mouse plasma protein binding (% unbound) 87.750 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 7.345 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 91.060 % High 1
rh-clint Rat hepatocyte intrinsic clearance 2.692 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 91.660 % High 1
rppb Rat plasma protein binding (% unbound) 85.310 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 928.966 uM High 1

Approvals:

DateAgencyCompanyOrphan
July 31, 2009 FDA ASTRAZENECA AB
Sept. 30, 2009 EMA 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
Lactic acidosis 63.31 20.15 34 3690 50429 90574294
Hypoglobulinaemia 62.17 20.15 10 3714 169 90624554
Diabetic ketoacidosis 50.12 20.15 23 3701 24384 90600339
Ketoacidosis 47.93 20.15 15 3709 5580 90619143
Acute kidney injury 44.47 20.15 60 3664 320327 90304396
Urinary tract obstruction 41.68 20.15 11 3713 2238 90622485
Blood glucose increased 33.08 20.15 29 3695 95217 90529506
Subacute cutaneous lupus erythematosus 32.35 20.15 10 3714 3572 90621151
Drug interaction 29.86 20.15 46 3678 276407 90348316
Febrile bone marrow aplasia 29.23 20.15 12 3712 9726 90614997
Inappropriate antidiuretic hormone secretion 26.87 20.15 14 3710 19491 90605232
Arrhythmia 25.84 20.15 18 3706 42314 90582409
Pancreatitis 25.73 20.15 22 3702 69804 90554919
Hypoglycaemia 23.71 20.15 21 3703 69827 90554896
Cardiac failure 22.43 20.15 25 3699 109471 90515252
Dehydration 21.88 20.15 33 3691 194414 90430309
Hypogammaglobulinaemia 21.72 20.15 10 3714 10664 90614059
Hypoglycaemic coma 21.43 20.15 7 3717 2983 90621740
Small intestinal obstruction 20.34 20.15 12 3712 21222 90603501
Cerebral infarction 20.30 20.15 13 3711 26583 90598140

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
Pancreatic carcinoma 71.91 19.74 29 4122 9477 42607707
Vertigo 50.64 19.74 35 4116 34312 42582872
Infection parasitic 45.12 19.74 10 4141 407 42616777
Insulin C-peptide decreased 44.80 19.74 7 4144 37 42617147
Diabetic ketoacidotic hyperglycaemic coma 40.66 19.74 8 4143 180 42617004
Gastrointestinal bacterial infection 40.09 19.74 10 4141 681 42616503
Pancreatitis 39.23 19.74 33 4118 43235 42573949
Dizziness 38.86 19.74 79 4072 249175 42368009
Blood glucose increased 34.31 19.74 39 4112 73660 42543524
Hypoglycaemia 31.88 19.74 34 4117 59820 42557364
Diabetes mellitus inadequate control 30.79 19.74 19 4132 15371 42601813
Dyspepsia 30.39 19.74 28 4123 41324 42575860
Hypoglycaemic coma 30.17 19.74 11 4140 2733 42614451
Angina pectoris 29.62 19.74 25 4126 32871 42584313
Acute kidney injury 28.23 19.74 89 4062 367248 42249936
Pancreatitis acute 27.17 19.74 24 4127 33540 42583644
Faeces soft 27.16 19.74 12 4139 4900 42612284
Abdominal pain upper 26.08 19.74 36 4115 82573 42534611
Volvulus 25.65 19.74 9 4142 2004 42615180
Large intestine polyp 25.31 19.74 14 4137 9251 42607933
Spleen congestion 24.94 19.74 6 4145 351 42616833
Post procedural erythema 24.71 19.74 3 4148 0 42617184
B-cell lymphoma 23.98 19.74 11 4140 4902 42612282
Drug effect less than expected 23.20 19.74 10 4141 3847 42613337
Suprapubic pain 23.11 19.74 6 4145 480 42616704
Ketoacidosis 23.08 19.74 11 4140 5341 42611843
Anal fissure 20.28 19.74 10 4141 5229 42611955

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
Pancreatic carcinoma 73.41 17.31 30 7325 14842 110567102
Ketoacidosis 69.80 17.31 26 7329 10061 110571883
Hypoglobulinaemia 68.06 17.31 12 7343 217 110581727
Acute kidney injury 67.01 17.31 137 7218 635293 109946651
Lactic acidosis 60.90 17.31 50 7305 92761 110489183
Hypoglycaemia 56.95 17.31 53 7302 116051 110465893
Hypoglycaemic coma 52.41 17.31 18 7337 5515 110576429
Pancreatitis 52.36 17.31 46 7309 93487 110488457
Diabetic ketoacidosis 51.30 17.31 33 7322 42025 110539919
Blood glucose increased 49.25 17.31 52 7303 132444 110449500
Insulin C-peptide decreased 41.72 17.31 7 7348 93 110581851
Infection parasitic 41.32 17.31 10 7345 884 110581060
Diabetic ketoacidotic hyperglycaemic coma 40.55 17.31 8 7347 271 110581673
Diabetes mellitus inadequate control 37.89 17.31 24 7331 29751 110552193
Gastrointestinal bacterial infection 36.74 17.31 10 7345 1408 110580536
Cerebral infarction 36.25 17.31 29 7326 51809 110530135
Vertigo 35.70 17.31 36 7319 86834 110495110
Dehydration 35.10 17.31 65 7290 279446 110302498
Cardiac failure 34.80 17.31 52 7303 187574 110394370
Pancreatitis acute 34.44 17.31 30 7325 60244 110521700
Large intestine polyp 32.10 17.31 17 7338 15100 110566844
Pemphigoid 30.49 17.31 18 7337 19689 110562255
Hypogammaglobulinaemia 30.18 17.31 18 7337 20058 110561886
Angina pectoris 29.68 17.31 28 7327 62267 110519677
B-cell lymphoma 27.22 17.31 12 7343 7142 110574802
Spleen congestion 25.22 17.31 6 7349 493 110581451
Subacute cutaneous lupus erythematosus 24.39 17.31 10 7345 4984 110576960
Volvulus 24.09 17.31 9 7346 3509 110578435
Renal cancer 23.08 17.31 13 7342 13021 110568923
Faeces soft 22.10 17.31 12 7343 11198 110570746
Post procedural erythema 21.70 17.31 3 7352 9 110581935
Peripheral arterial occlusive disease 21.31 17.31 11 7344 9269 110572675
Hyperglycaemia 20.88 17.31 27 7328 85063 110496881
Urinary tract obstruction 20.72 17.31 9 7346 5168 110576776
Drug effect less than expected 20.72 17.31 10 7345 7310 110574634
Glycosylated haemoglobin increased 20.43 17.31 15 7340 23604 110558340
Suprapubic pain 20.38 17.31 6 7349 1119 110580825
Arrhythmia 20.16 17.31 24 7331 69551 110512393
Inappropriate antidiuretic hormone secretion 19.64 17.31 17 7338 33834 110548110
Urosepsis 19.01 17.31 16 7339 30659 110551285
Anal fissure 17.89 17.31 10 7345 9871 110572073
Scab 17.67 17.31 11 7344 13225 110568719

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 D004791 Enzyme Inhibitors
MeSH PA D006728 Hormones
MeSH PA D007004 Hypoglycemic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D054795 Incretins
MeSH PA D054873 Dipeptidyl-Peptidase IV Inhibitors
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:68612 EC 3.4.14.5 (dipeptidyl-peptidase IV) inhibitor
CHEBI has role CHEBI:35554 cardiovascular drug

Related Drugs by ATC class:

A10BD Combinations of oral blood glucose lowering drugs 19 drugs
A10BH Dipeptidyl peptidase 4 (DPP-4) inhibitors 9 drugs

Drug Use | Suggest Off label Use Form| |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
10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 6515117 Oct. 4, 2025 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8501698 June 20, 2027 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN 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 **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 Feb. 27, 2017 DISCN TABLET ORAL 8361972 March 21, 2028 TREATMENT OF TYPE 2 DIABETES MELLITUS
5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** QTERN ASTRAZENECA AB N209091 May 2, 2019 DISCN 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
1GM;EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 DISCN TABLET, EXTENDED RELEASE ORAL Oct. 11, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
1GM;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 DISCN TABLET, EXTENDED RELEASE ORAL Oct. 11, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
500MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** KOMBIGLYZE XR ASTRAZENECA AB N200678 Nov. 5, 2010 DISCN TABLET, EXTENDED RELEASE ORAL Oct. 11, 2027 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

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
Dipeptidyl peptidase 4 Enzyme IC50 8.72 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
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
369212 MMSL
d07467 MMSL
013204 NDDF
013205 NDDF
443066009 SNOMEDCT_US
443087004 SNOMEDCT_US
734452007 SNOMEDCT_US
BJM PDB_CHEM_ID
CHEMBL385517 ChEMBL_ID
945667-22-1 SECONDARY_CAS_RN
9GB927LAJW INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Saxagliptin and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 43598-618 TABLET, FILM COATED, EXTENDED RELEASE 2.50 mg ORAL ANDA 27 sections
Saxagliptin and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 43598-619 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 27 sections
Saxagliptin and Metformin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 43598-620 TABLET, FILM COATED, EXTENDED RELEASE 5 mg ORAL ANDA 27 sections
ONGLYZA HUMAN PRESCRIPTION DRUG LABEL 1 54868-6309 TABLET, FILM COATED 5 mg ORAL NDA 31 sections
Saxagliptin Human Prescription Drug Label 1 65862-825 TABLET, FILM COATED 2.50 mg ORAL ANDA 27 sections
Saxagliptin Human Prescription Drug Label 1 65862-826 TABLET, FILM COATED 5 mg ORAL ANDA 27 sections
SAXAGLIPTIN HUMAN PRESCRIPTION DRUG LABEL 1 68462-726 TABLET, FILM COATED 2.50 mg ORAL ANDA 28 sections
SAXAGLIPTIN HUMAN PRESCRIPTION DRUG LABEL 1 68462-727 TABLET, FILM COATED 5 mg ORAL ANDA 28 sections