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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Accenture
Mallinckrodt
US Department of Justice
Julphar
Cipla
Argus Health
Johnson and Johnson
Cantor Fitzgerald

Generated: August 18, 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
2892 I II 3/8/1977 HEINRICH MACK NACHF 5-FLUOROURACIL
3062 A II 11/9/1977 TEVA PHARMACEUTICAL INDUSTRIES LTD 5-FLUOROURACIL
4247 I II 7/21/1981 PFANSTIEHL LABORATORIES INC FTORAFUR (1-TETRAHYDRO-2-FURANYL) 5-FLUOROURACIL) PROD CODE #F-107
6098 I II 10/23/1985 ANDARD MOUNT INTERNATIONAL LTD 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Mallinckrodt
Federal Trade Commission
QuintilesIMS
Julphar
Argus Health
Daiichi Sankyo
Fish and Richardson

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