Imatinib
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 tablets, for oral use Initial U.S. Approval: 2001
Approved
Approval ID
559dd8e5-11f9-70cd-3fb0-9f9eb8484a37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 14, 2022
Manufacturers
FDA
Dr.Reddy's Laboratories Inc
DUNS: 802315887
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-344
Application NumberANDA206547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2022
FDA Product Classification
INGREDIENTS (12)
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Imatinib MesylateActive
Quantity: 100 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Imatinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-345
Application NumberANDA206547
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imatinib
Product Specifications
Route of AdministrationORAL
Effective DateNovember 14, 2022
FDA Product Classification
INGREDIENTS (12)
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
Imatinib MesylateActive
Quantity: 400 mg in 1 1
Code: 8A1O1M485B
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Polyethylene Glycol 3350Inactive
Code: G2M7P15E5P
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Sodium Stearyl FumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT