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Last Updated: January 24, 2020

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Drug Master Files for: HYDROXYUREA

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HYDROXYUREA Drug Master Files

DMF No. Status Type Submission Date Holder Subject
1077 I II 8/25/1967 ER SQUIBB AND SONS INC MANUFACTURE OF HYDROXYUREA
11899 A II 3/25/1996 OLON SPA HYDROXYUREA
12754 A II 11/14/1997 EUTICALS SPA HYDROXYUREA
16458 I II 2/21/2003 CHEMSPEC HYDROXYUREA
20615 A II 6/15/2007 QILU TIANHE PHARMACEUTICAL CO LTD HYDROXYUREA USP (NON-STERILE BULK)
2258 I II 4/9/1974 FERMENTA FRANCE SA HYDROXYUREA BY OLMACO OF EMPERNON,FRANCE (FORMERLY HELD BY OLMACO)
2259 I II 4/11/1974 SQUIBB HYDROXYUREA
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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