Basic Information
imatinib mesylate
68001-491
Regulatory Information
68001-491
ANDA078340
C73584
September 21, 2023
USA
These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB MESYLATE tablets, for oral use Initial U.S. Approval: 2001
HUMAN PRESCRIPTION DRUG LABEL
5
Company Information
985523874
Active Ingredients
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
COPOVIDONE K25-31
Code: D9C330MD8B
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
CROSPOVIDONE (120 .MU.M)
Code: 68401960MK
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
Active Moieties
IMATINIB
Code: BKJ8M8G5HI