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Last Updated: July 24, 2024

Drug Master Files for: Fdc Ltd


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Fdc Ltd Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10456 A II 8/9/1993 FDC LTD ECONAZOLE NITRATE USP
16449 I II 3/4/2003 FDC LTD METAXALONE
16632 A II 6/12/2003 FDC LTD FLUCONAZOLE
16802 I II 8/27/2003 FDC LTD KETOCONAZOLE
17446 I II 5/27/2004 FDC LTD DANTROLENE SODIUM
20855 A II 9/17/2007 FDC LTD BRIMONIDINE TARTRATE
20856 A II 9/17/2007 FDC LTD DORZOLAMIDE HYDROCHLORIDE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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