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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 206547

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NDA 206547 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 206547
Tradename:IMATINIB MESYLATE
Applicant:Dr Reddys
Ingredient:imatinib mesylate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206547
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 206547
Suppliers and Packaging for NDA: 206547
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547 ANDA Dr.Reddy's Laboratories Inc 43598-344 43598-344-10 1000 TABLET in 1 CONTAINER (43598-344-10)
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 206547 ANDA Dr.Reddy's Laboratories Inc 43598-344 43598-344-30 30 TABLET in 1 CONTAINER (43598-344-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 100MG BASE
Approval Date:Aug 13, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Aug 13, 2018TE:ABRLD:No

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