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Generated: January 18, 2019

DrugPatentWatch Database Preview

Drug Master Files for: praziquantel

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praziquantel Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11631 I II 8/23/1995 SHANGHAI NUMBER 6 PHARMACEUTICAL FACTORY PRAZIQUANTEL
13999 A II 2/24/1999 PCAS PRAZIQUANTEL
14352 A II 8/19/1999 CIPLA LTD PRAZIQUANTEL USP
23887 I II 6/15/2010 SEQUENT SCIENTIFIC LTD PRAZIQUANTEL
26076 A II 5/21/2012 SOLARA A PHARMA SCIENCES LTD PRAZIQUANTEL
26837 A II 1/14/2013 SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTD PRAZIQUANTEL
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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