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Last Updated: June 13, 2021

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Drug Master Files for: HEPARIN SODIUM


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HEPARIN SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10013 I II 12/14/1992 CHISSO CORP HEPARIN - CELLUFINE B
10015 I II 12/14/1992 CHISSO CORP HEPARIN - CELLUFINE
10052 I II 12/9/1992 DIOSYNTH BV HEPARIN SODIUM
1007 I II 11/1/1966 HOFFMANN LA ROCHE INC COMPOSITION & GR OF INJECTABLE SOLUTION OF HEPARINOID RO 1-8307
10477 I II 9/3/1993 LEO PHARMACEUTICAL PRODUCTS LTD WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF HEPARIN SODIUM
10589 I II 11/22/1993 LEO PHARMACEUTICAL PRODUCTS LTD HEPARIN SODIUM DRUG SUBSTANCE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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