Basic Information
Saxagliptin
65162-060
Regulatory Information
65162-060
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
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYDROCHLORIC ACID
Code: QTT17582CB
Class Code: IACT
CELLULOSE, MICROCRYSTALLINE
Code: OP1R32D61U
Class Code: IACT
POVIDONE
Code: FZ989GH94E
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
HYPROMELLOSES
Code: 3NXW29V3WO
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
Active Moieties
SAXAGLIPTIN ANHYDROUS
Code: 8I7IO46IVQ