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Generated: December 12, 2018

DrugPatentWatch Database Preview

Drug Master Files for: MISOPROSTOL

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MISOPROSTOL Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12729 I II 11/7/1997 PHARMATECH INTERNATIONAL INC MISOPROSTOL
14390 I II 9/7/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD MISOPROSTOL
14391 I II 9/7/1999 TEVA PHARMACEUTICAL INDUSTRIES LTD MISOPROSTOL HPMC DISPERSION 1:100
14500 I II 10/21/1999 EVERLIGHT CHEMICAL INDUSTRIAL CORP MISOPROSTOL
15017 A II 8/17/2000 EVERLIGHT CHEMICAL INDUSTRIAL CORP MISOPROSTOL
15044 I II 9/13/2000 DAIICHI FINE CHEMICAL CO LTD MISOPROSTOL 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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