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Last Updated: November 22, 2024

Drug Master Files for: probucol


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probucol Drug Master Files

DMF No. Status Type Submission Date Holder Subject
17355 A II 4/26/2004 SCI PHARMTECH INC PROBUCOL
2167 I II 10/17/1973 HOECHST MARION ROUSSEL INC PROBUCOL (DH-581)
7579 I II 7/18/1988 MEDICHEM SA PROBUCOL
7761 I II 11/22/1988 SUMIKA FINE CHEMICALS CO LTD PROBUCOL
8258 I II 10/20/1989 WYCKOFF CHEMICAL CO INC PROBUCOL
8286 I II 11/14/1989 ZAMBON SPA PROBUCOL USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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