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Last Updated: July 26, 2021

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Drug Master Files for: miconazole


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miconazole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10518 A II 9/30/1993 OLON SPA MICONAZOLE NITRATE
10579 I II 11/16/1993 KV PHARMACEUTICAL CO MICONAZOLE VAGINAL CREAM
10912 I II 5/20/1994 JANSSEN PHARMACEUTICA NV MICONAZOLE DRUG SUBSTANCE
10913 A II 5/20/1994 JANSSEN PHARMACEUTICA NV MICONAZOLE NITRATE DRUG SUBSTANCE
10970 I II 6/28/1994 GUANGDONG PHARMACEUTICAL FACTORY MICONAZOLE NITRATE
11562 A II 6/20/1995 CORDEN PHARMA BERGAMO SPA MICONAZOLE NITRATE
12455 I II 4/7/1997 GUFIC BIOSCIENCES LTD MICONAZOLE NITRATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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