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Last Updated: September 26, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079179

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NDA 079179 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, Wockhardt Bio Ag, and Zydus Pharms, and is included in thirteen NDAs. It is available from twenty suppliers. Additional details are available on the IMATINIB MESYLATE profile page.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 079179
Tradename:IMATINIB MESYLATE
Applicant:Apotex
Ingredient:imatinib mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 079179
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 079179
Suppliers and Packaging for NDA: 079179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA Major Pharmaceuticals 0904-6621 0904-6621-04 30 BLISTER PACK in 1 CARTON (0904-6621-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA Major Pharmaceuticals 0904-6901 0904-6901-04 30 BLISTER PACK in 1 CARTON (0904-6901-04) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Aug 5, 2016TE:ABRLD:No

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