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Generated: May 21, 2019

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Drug Master Files for: fluocinolone

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fluocinolone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15572 I II 7/30/2001 SICOR SPA FLUOCINOLONE ACETONIDE 1,2-DIHYDRO
16086 I II 8/9/2002 PHARMACIA AND UPJOHN DIHYDROFLUOCINOLONE ACETONIDE
17395 A II 5/19/2004 FARMABIOS SPA FLUOCINOLONE ACETONIDE
23875 A II 6/9/2010 TEVA PHARMACEUTICAL INDUSTRIES LTD FLUOCINOLONE ACETONIDE - PROCESS II
2787 I II 11/2/1976 ANTIBIOTICOS SPA FLUOCINOLONE ACETONIDE
2944 I II 5/11/1977 NOBEL CHEMICALS AB DIV FINE CHEMICALS INC FLUOCINOLONE ACETONIDE
418 I II 1/3/1961 DR REDDYS LABORATORIES LTD FLUOCINOLONE ACETONIDE
DMF No. Status Type Submission Date Holder Subject

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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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