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
NDC Product Code43598-344
Application NumberANDA206547
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 14, 2022
Generic NameImatinib
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
NDC Product Code43598-345
Application NumberANDA206547
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 14, 2022
Generic NameImatinib
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