Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
Mallinckrodt
Colorcon
McKesson
Harvard Business School

Last Updated: December 10, 2019

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Drug Master Files for: CALCIPOTRIENE

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CALCIPOTRIENE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
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
10839 I II 3/30/1994 LEO PHARMA AS CALCIPOTRIENE SCALP SOLUTION
10843 I II 3/30/1994 LEO PHARMACEUTICAL PRODUCTS LTD FACILITY FOR THE MANUFACTURE OF CALCIPOTRIENE SCALP SOLUTION IN BALLERUP, DENMARK.
16928 I II 10/20/2003 SAFC INC CALCIPOTRIENE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

McKesson
Moodys
Colorcon
Medtronic
AstraZeneca
Johnson and Johnson

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