Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 16, 2019

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Drug Master Files for: fluocinonide

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fluocinonide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
14151 A II 5/14/1999 TARO PHARMACEUTICAL INDUSTRIES LTD FLUOCINONIDE USP MICRONIZED
21261 A II 1/23/2008 TEVA PHARMACEUTICAL INDUSTRIES LTD FLUOCINONIDE (NEW PROCESS)
21430 A II 3/13/2008 FARMABIOS SPA FLUOCINONIDE, MICRONIZED BP/USP
3112 I II 1/3/1978 ANTIBIOTICOS SPA FLUOCINONIDE (BULK, NON STERILE, NON-MICRONIZED & MICRONIZED)
4591 A II 7/9/1982 TEVA PHARMACEUTICAL INDUSTRIES LTD FLUOCINONIDE
7384 I II 2/19/1988 CESQUISA SA FLUOCINONIDE
7391 I II 3/22/1988 FARMABOIS FLUOCINONIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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