MedPath
FDA Product

Saxagliptin

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

Basic Information

Saxagliptin

65862-825

Regulatory Information

65862-825

ANDA205972

C73584

January 9, 2024

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

2

Company Information

650082092

Active Ingredients

ASCORBIC ACID

Code: PQ6CK8PD0R

Class Code: IACT

GLYCERYL MONOSTEARATE

Code: 230OU9XXE4

Class Code: IACT

CROSPOVIDONE (35 .MU.M)

Code: 40UAA97IT9

Class Code: IACT

HYDROXYPROPYL CELLULOSE (45000 WAMW)

Code: 8VAB711C5E

Class Code: IACT

FERRIC OXIDE YELLOW

Code: EX438O2MRT

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MANNITOL

Code: 3OWL53L36A

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 301

Code: W7YXH6D4BD

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

MICROCRYSTALLINE CELLULOSE 102

Code: PNR0YF693Y

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FD&C YELLOW NO. 5

Code: I753WB2F1M

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

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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