ONGLYZA

Basic Information

Product Name

ONGLYZA

FDA Product Code

54868-6309

Regulatory Information

NDC Product Code

54868-6309

Application Number

NDA022350

Marketing Category

C73594

Effective Date

January 9, 2012

Territorial Authority

USA

FDA Title

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

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

cellulose, microcrystalline

Code: OP1R32D61U

Class Code: IACT

croscarmellose sodium

Code: M28OL1HH48

Class Code: IACT

magnesium stearate

Code: 70097M6I30

Class Code: IACT

saxagliptin hydrochloride

Quantity: 5 mg in 1 1

Code: Z8J84YIX6L

Class Code: ACTIM

Active Moieties

saxagliptin

Code: 9GB927LAJW

Basic Information

Regulatory Information

Company Information

Active Ingredients

lactose monohydrate

cellulose, microcrystalline

croscarmellose sodium

magnesium stearate

Active Moieties

saxagliptin