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Generated: November 19, 2018

DrugPatentWatch Database Preview

Drug Master Files for: fluorouracil

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fluorouracil Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1138 I II 2/2/1968 INTERNATL CHEM & NUCLEAR PHARMS INC 5-FLUOROURACIL
1226 I II 8/21/1968 PCR INC 5-FLUOROURACIL
12738 A II 11/11/1997 AMCOL HEALTH AND BEAUTY SOLUTIONS INC FLUOROURACIL IN MICROSPONGE? POLYMER (FLUROURACIL IN METHYL METHACRYLATE/DIMETHACRYLATE CROSSPOLYMER)
17832 I II 9/8/2004 NANTONG GENERAL PHARMACEUTICAL FACTORY FLUOROURACIL
18478 A II 6/28/2005 NANTONG JINGHUA PHARMACEUTICAL CO LTD FLUOROURACIL USP
18975 I II 11/28/2005 DSM NUTRITIONAL PRODUCTS LTD 5-FLUOROURACIL
21774 A II 6/30/2008 DCS PHARMA AG FLUOROURACIL
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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