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Last Updated: March 28, 2024

Drug Master Files for: dinoprost tromethamine


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dinoprost tromethamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10621 I II 12/15/1993 CAYMAN PHARMA SRO PROSTAGLANDIN E2 (DINOPROSTONE)
11274 A II 12/27/1994 KYOWA PHARMA CHEMICAL CO LTD DINOPROSTONE DRUG SUBSTANCE
11563 A II 7/6/1995 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD DINOPROSTONE (PROSTAGLANDIN E2)
23248 I II 11/9/2009 CHINOIN PHARMACEUTICAL AND CHEMICAL WORKS PRIVATE CO LTD DINOPROST
5202 A II 1/3/1984 PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC DINOPROSTONE USP
5319 A II 4/6/1984 PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC DINOPROST TROMETHAMINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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