Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
US Army
Johnson and Johnson
Daiichi Sankyo
Julphar
Federal Trade Commission

Generated: July 23, 2019

DrugPatentWatch Database Preview

Drug Master Files for: memantine

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memantine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
18436 A II 6/17/2005 UNION QUIMICO FARMACEUTICA SA (UQUIFA SA) MEMANTINE HYDROCHLORIDE
18562 A II 7/29/2005 OLON SPA MEMANTINE HYDROCHLORIDE
19024 I II 12/14/2005 ESTEVE QUIMICA SA MEMANTINE HYDROCHLORIDE
19465 A II 5/22/2006 INDUSTRIALE CHIMICA SRL MEMANTINE HYDROCHLORIDE USP
19549 A II 6/20/2006 AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA MEMANTINE HYDROCHLORIDE
20151 I II 4/2/2007 TAI HENG INDUSTRY CO LTD MEMANTINE HYDROCHLORIDE
20362 A II 3/23/2007 MYLAN LABORATORIES LTD MEMANTINE HYDROCHLORIDE USP
DMF No. Status Type Submission Date Holder Subject

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Drug Master File Glossary

STATUS OF DMFS

  • A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
  • I = Inactive
  • N = Not an assigned number
  • P = DMF Pending Filing Review

TYPES OF DMFs

  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
  • Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
  • Type III Packaging Material
  • Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
  • Type V FDA Accepted Reference Information

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Express Scripts
Cantor Fitzgerald
Citi
McKesson
AstraZeneca

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