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Last Updated: November 4, 2024

Drug Master Files for: Leo Pharm


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Leo Pharm Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10477 I II 9/3/1993 LEO PHARMACEUTICAL PRODUCTS LTD WEXPORT LTD. FACILITIES IN LITTLE ISLAND, CORK, IRELAND FOR THE MANUFACTURE OF HEPARIN SODIUM
10514 A II 10/8/1993 LEO PHARMA AS CALCIPOTRIENE HYDRATE DRUG SUBSTANCE
10515 A II 10/8/1993 LEO PHARMA AS CALCIPOTRIENE CREAM DRUG PRODUCT
10589 I II 11/22/1993 LEO PHARMACEUTICAL PRODUCTS LTD HEPARIN SODIUM DRUG SUBSTANCE
10596 I II 12/7/1993 LEO PHARMACEUTICAL PRODUCTS LTD TINZAPARIN SODIUM DRUG SUBSTANCE
10597 I II 12/7/1993 LEO PHARMACEUTICAL PRODUCTS LTD INNOHEP INJECTION 20,000 ANTI-XA IR/ML
10839 I II 3/30/1994 LEO PHARMA AS CALCIPOTRIENE SCALP SOLUTION
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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