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:

McKesson
Harvard Business School
Johnson and Johnson
Colorcon
Boehringer Ingelheim
AstraZeneca

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Drug Master Files for: AZELAIC ACID

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AZELAIC ACID Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10857 I II 4/5/1994 CU CHEMIE UETIKON GMBH AZELAIC ACID
11615 A II 8/4/1995 BASF SE DERMAZ 88 (AZELAIC ACID)
16758 I II 8/11/2003 COGNIS CORP DERMAZ(TM) 95 AZELAIC ACID
19481 A II 5/31/2006 BASF SE DERMAZ 99 (AZELAIC ACID)
28190 A II 6/26/2014 BAYER AG AZELAIC ACID (A)
29484 A II 12/1/2015 TARO PHARMACEUTICAL INDUSTRIES LTD AZELAIC ACID, MICRONIZED
29924 A II 3/11/2016 GLENMARK PHARMACEUTICALS LTD AZELAIC ACID
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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
Baxter
Dow
Merck
Boehringer Ingelheim
Johnson and Johnson

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