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Baxter
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Express Scripts
Queensland Health
US Department of Justice
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Boehringer Ingelheim
Daiichi Sankyo
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Generated: November 14, 2018

DrugPatentWatch Database Preview

Drug Master Files for: acamprosate

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acamprosate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11995 A II 6/10/1996 MERCK SANTE SAS CALCIUM ACAMPROSATE NEW DRUG SUBSTANCE
15819 I II 1/23/2002 LIPHA SAS HOMOTAURINE (CALCIUM ACAMPROSATE INTERMEDIATE)
21348 A II 2/20/2008 ANGELINI ACRAF SPA ACAMPROSATE CALCIUM
21481 A II 3/24/2008 IND SWIFT LABORATORIES LTD ACAMPROSATE CALCIUM
21807 A II 7/14/2008 OLON SPA ACAMPROSATE CALCIUM
22625 A II 3/13/2009 OLON SPA ACAMPROSATE CALCIUM
23973 I II 8/25/2010 WUHAN WUYAO PHARMACEUTICAL CO LTD ACAMPROSATE CALCIUM, NON-STERILE BULK DRUG SUBSTANCE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
US Army
Dow
Boehringer Ingelheim
McKesson
Mallinckrodt
Daiichi Sankyo
Cantor Fitzgerald
Argus Health

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