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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Dow
Healthtrust
Federal Trade Commission
Covington
Daiichi Sankyo
Mallinckrodt
Chubb
Teva

Generated: April 25, 2018

DrugPatentWatch Database Preview

Drug Master Files for: AMPRENAVIR

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AMPRENAVIR Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13060 I II 7/7/1998 CATALENT FRANCE BEINHEIM SA AMPRENAVIR 50 AND 150 MG SOFT GELATIN CAPSULES
25569 A II 2/24/2012 LUPIN LTD FOSAMPRENAVIR CALCIUM
25578 A II 11/29/2011 MYLAN LABORATORIES LTD FOSAMPRENAVIR CALCIUM
25649 I II 1/16/2012 SUN PHARMACEUTICAL INDUSTRIES LTD FOSAMPRENAVIR CALCIUM
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

McKesson
AstraZeneca
Colorcon
US Department of Justice
Dow
Cerilliant
Farmers Insurance
Baxter
Medtronic

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