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Generated: September 25, 2018

DrugPatentWatch Database Preview

Drug Master Files for: ZALEPLON

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ZALEPLON Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11747 I II 11/13/1995 ZACH SYSTEM SPA ZALEPLON
16785 I II 8/20/2003 AMINO CHEMICALS LTD ZALEPLON
17230 I II 3/12/2004 MEDICHEM SA ZALEPLON
17565 A II 7/22/2004 TEVA PHARMACEUTICAL INDUSTRIES LTD ZALEPLON
18022 A II 1/26/2005 CIPLA LTD ZALEPLON
19015 I II 12/13/2005 GADOR SA ZALEPLON
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

AstraZeneca
Healthtrust
Fuji
McKinsey
QuintilesIMS
Boehringer Ingelheim
Argus Health
Mallinckrodt
Moodys

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