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FDA Product

ONGLYZA

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

Basic Information

ONGLYZA

0310-6100

Regulatory Information

0310-6100

NDA022350

C73594

October 24, 2019

USA

These highlights do not include all the information needed to use ONGLYZA safely and effectively. See full prescribing information for ONGLYZA. ONGLYZA (saxagliptin) tablets, for oral useInitial U.S. Approval: 2009

HUMAN PRESCRIPTION DRUG LABEL

23

Company Information

054743190

Active Ingredients

magnesium stearate

Code: 70097M6I30

Class Code: IACT

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

croscarmellose sodium

Code: M28OL1HH48

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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