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 use Initial U.S. Approval: 2001
Approved
Approval ID
82eb01e0-8685-4f06-8a72-7663e8ded38f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 10, 2022
Manufacturers
FDA
Qilu Pharmaceutical Co., Ltd.
DUNS: 653878256
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 Code67184-0533
Application NumberANDA212135
Product Classification
M
Marketing Category
C73584
G
Generic Name
imatinib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2022
FDA Product Classification
INGREDIENTS (12)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
imatinib mesylate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67184-0532
Application NumberANDA212135
Product Classification
M
Marketing Category
C73584
G
Generic Name
imatinib mesylate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 10, 2022
FDA Product Classification
INGREDIENTS (12)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
IMATINIB MESYLATEActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM