Metformin / saxagliptin Extended Release Oral Tablet

Brand(s)
Kombiglyze
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Astrazeneca Pharmaceuticals Lp (2015-08-28)
Oldest Current Product
2010-11-05
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\METFORMIN:SAXAGLIPTIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: SAXAGLIPTIN HYDROCHLORIDE
SPL Active
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN HYDROCHLORIDE: SAXAGLIPTIN HYDROCHLORIDE
SPL Moiety
ORAL\TABLET, FILM COATED, EXTENDED RELEASE\METFORMIN: SAXAGLIPTIN ANHYDROUS

product(s) by strength(s)

24 hr metformin hydrochloride 1000 mg / saxagliptin 2.5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1000034222KombiglyzeNDAE.R. Squibb & Sons, L.L.C.2010-11-052017-05-31METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200678c1ac4f63-695c-6bd6-4a7f-ecb97e03569e

24 hr metformin hydrochloride 1000 mg / saxagliptin 5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106145KombiglyzeNDAAstrazeneca Pharmaceuticals Lp2014-12-04METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200678fbd25da4-ebe6-45c9-beb8-93523d11a0b4

24 hr metformin hydrochloride 500 mg / saxagliptin 5 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003106135KombiglyzeNDAAstrazeneca Pharmaceuticals Lp2014-12-04METFORMIN HYDROCHLORIDE, SAXAGLIPTIN HYDROCHLORIDEORALTABLET, FILM COATED, EXTENDED RELEASENDA200678fbd25da4-ebe6-45c9-beb8-93523d11a0b4

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA200678KOMBIGLYZE XRASTRAZENECA AB2010-11-05p8628799, SUBSTANCE
pRE44186, 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, SUBSTANCE
ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN COMBINATION WITH METFORMIN AND A SULFONYLUREA ADDED TO THE LABELING [2016-05-24]
NEW CHEMICAL ENTITY [2014-07-31]
NDA200678_001, NDA200678_002, NDA200678_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA200678_001RXMETFORMIN HYDROCHLORIDE (500MG), SAXAGLIPTIN HYDROCHLORIDE (EQ 5MG BASE)ORALTABLET, EXTENDED RELEASEFalse2010-11-05KOMBIGLYZE XR
2NDA200678_002RXMETFORMIN HYDROCHLORIDE (1GM), SAXAGLIPTIN HYDROCHLORIDE (EQ 5MG BASE)ORALTABLET, EXTENDED RELEASETrue2010-11-05KOMBIGLYZE XR
3NDA200678_003RXMETFORMIN HYDROCHLORIDE (1GM), SAXAGLIPTIN HYDROCHLORIDE (EQ 2.5MG BASE)ORALTABLET, EXTENDED RELEASEFalse2010-11-05KOMBIGLYZE XR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p8628799 (view patent)2025-07-13NDA200678
2pRE44186 (view patent)2023-07-31NDA200678, NDA022350saxagliptin Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1c1ac4f63-695c-6bd6-4a7f-ecb97e03569e (view SPL)These highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2010prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2013-05-247000034222, 000034221, 000034223
2fbd25da4-ebe6-45c9-beb8-93523d11a0b4 (view SPL)These highlights do not include all the information needed to use KOMBIGLYZE XR safely and effectively. See full prescribing information for KOMBIGLYZE XR. KOMBIGLYZE XR (saxagliptin and metformin hydrochloride extended-release) tablets, for oral useInitial U.S. Approval: 2010prescriptionHuman PrescriptionAstrazeneca Pharmaceuticals Lp2015-08-283003106135, 003106145, 003106125

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII