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Last Updated: April 23, 2024

Drug Master Files for: alprostadil


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alprostadil Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10415 I II 8/10/1993 ONO PHARMACEUTICAL CO LTD ALPROSTADIL ALFADEX I.V.
10948 A II 6/20/1994 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD ALPROSTADIL
11845 I II 2/6/1996 NISSAN CHEMICAL INDUSTRIES LTD ALPROSTADIL
12569 I II 7/2/1997 CASCADE BIOCHEMICAL LTD ALPROSTADIL
21233 A II 1/15/2008 EVERLIGHT CHEMICAL INDUSTRIAL CORP Alprostadil
27130 A II 4/26/2013 ONO PHARMACEUTICAL CO LTD ALPROSTADIL ALFADEX
9688 A II 5/13/1992 CAYMAN PHARMA SRO ALPROSTADIL
>DMF No. >Status >Type >Submission Date >Holder >Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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