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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208302

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NDA 208302 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex Inc, Breckenridge, Dr Reddys, Mylan, Natco Pharma Ltd, Shilpa Medicare Ltd, Sun Pharm, Teva Pharms Usa, West-ward Pharms Int, and Wockhardt Bio Ag, and is included in eleven 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 208302
Tradename:IMATINIB MESYLATE
Applicant:Shilpa Medicare Ltd
Ingredient:imatinib mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208302
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 208302
Suppliers and Packaging for NDA: 208302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208302 ANDA Ascend Laboratories, LLC 67877-633 67877-633-90 90 TABLET, FILM COATED in 1 BOTTLE (67877-633-90)
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208302 ANDA Ascend Laboratories, LLC 67877-634 67877-634-30 30 TABLET, FILM COATED in 1 BOTTLE (67877-634-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Jan 17, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Jan 17, 2019TE:ABRLD:No

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