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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Cipla
Boehringer Ingelheim
Federal Trade Commission
QuintilesIMS
McKesson
US Army
Cerilliant
Medtronic

Generated: April 22, 2018

DrugPatentWatch Database Preview

Drug Master Files for: ambrisentan

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ambrisentan Drug Master Files

DMF No. Status Type Submission Date Holder Subject
24505 A II 12/21/2010 MYLAN LABORATORIES LTD AMBRISENTAN
25134 I II 9/9/2011 WATSON PHARMA PRIVATE LTD AMBRISENTAN
29490 A II 6/30/2015 CIPLA LTD AMBRISENTAN
26156 A II 6/8/2012 MSN LABORATORIES PRIVATE LTD AMBRISENTAN [ROUTE CODE - AB]
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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:

UBS
Mallinckrodt
Deloitte
Federal Trade Commission
Cerilliant
Cantor Fitzgerald
Harvard Business School
QuintilesIMS
AstraZeneca

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