MedPath
FDA Product

Saxagliptin

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Saxagliptin

65162-059

Regulatory Information

65162-059

ANDA205941

C73584

August 9, 2023

USA

These highlights do not include all the information needed to use SAXAGLIPTIN TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN TABLETS. SAXAGLIPTIN tablets, for oral use Initial U.S. Approval: 2009

HUMAN PRESCRIPTION DRUG LABEL

8

Company Information

123797875

Active Ingredients

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

POVIDONE

Code: FZ989GH94E

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

SAXAGLIPTIN HYDROCHLORIDE

Quantity: 2.5 mg in 1 1

Code: Z8J84YIX6L

Class Code: ACTIM

Active Moieties

SAXAGLIPTIN ANHYDROUS

Code: 8I7IO46IVQ

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