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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Federal Trade Commission
McKesson
Covington
Deloitte
McKinsey
Merck
Fuji

Generated: December 15, 2018

DrugPatentWatch Database Preview

Drug Master Files for: DIPHENHYDRAMINE HYDROCHLORIDE

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DIPHENHYDRAMINE HYDROCHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11097 A II 9/23/1994 ALBEMARLE CORP DIPHENHYDRAMINE CITRATE, USP
12360 I II 1/31/1997 EURAND AMERICA INC DIPHENHYDRAMINE CITRATE (MICROCAPS)
1237 I II 9/16/1968 GANES CHEMICALS INC PENNSVILLE DIV DIPHENHYDRAMINE HYDROCHLORIDE
19737 A II 9/6/2006 BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTD DIPHENHYDRAMINE HYDROCHLORIDE
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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 hundreds of leading biopharmaceutical companies globally:

Accenture
Cerilliant
Daiichi Sankyo
Chubb
Merck
Harvard Business School
Fuji
US Department of Justice
Argus Health

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