Imatinib Mesylate
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 useInitial U.S. Approval: 2001
Approved
Approval ID
7fd8afed-3bb5-4029-a347-665e032d56e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2020
Manufacturers
FDA
Wockhardt USA LLC.
DUNS: 170508365
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
imatinib mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-793
Application NumberANDA208429
Product Classification
M
Marketing Category
C73584
G
Generic Name
imatinib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2020
FDA Product Classification
INGREDIENTS (9)
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
imatinib mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-794
Application NumberANDA208429
Product Classification
M
Marketing Category
C73584
G
Generic Name
imatinib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2020
FDA Product Classification
INGREDIENTS (9)
IMATINIB MESYLATEActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT