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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 208429


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NDA 208429 describes IMATINIB MESYLATE, which is a drug marketed by Amneal Pharms, Apotex, Breckenridge, Chartwell Rx, Dr Reddys, Eugia Pharma, Hikma, Mylan, Natco Pharma Ltd, Qilu Pharm Hainan, Shilpa, Sun Pharm, Teva Pharms Usa, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-two 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-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 208429
Tradename:IMATINIB MESYLATE
Applicant:Chartwell Rx
Ingredient:imatinib mesylate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 208429
Suppliers and Packaging for NDA: 208429
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208429 ANDA Chartwell RX, LLC 62135-658 62135-658-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-658-90)
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208429 ANDA Chartwell RX, LLC 62135-659 62135-659-30 30 TABLET, FILM COATED in 1 BOTTLE (62135-659-30)

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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