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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Dow
Deloitte
Covington
Healthtrust
Colorcon
Accenture
Farmers Insurance
Johnson and Johnson
Chinese Patent Office
Mallinckrodt

Generated: December 17, 2017

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 Apotex Inc, Mylan Pharms Inc, Sun Pharma Global, and Teva Pharms Usa, and is included in four NDAs. It is available from ten suppliers. Additional details are available on the IMATINIB MESYLATE profile page.

The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-one drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.

Summary for 079179

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antineoplastics
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 AvKARE, Inc. 42291-351 42291-351-90 90 TABLET, FILM COATED in 1 BOTTLE (42291-351-90)
IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 079179 ANDA AvKARE, Inc. 42291-352 42291-352-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-352-30)

Summary for product number 001

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

Summary for product number 002

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


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Serving leading biopharmaceutical companies globally:

Express Scripts
Accenture
Cipla
Daiichi Sankyo
Fish and Richardson
Chinese Patent Office
Teva
Mallinckrodt
Johnson and Johnson
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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