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Last Updated: January 18, 2020

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
19986 A II 11/15/2006 WANBURY LTD DIPHENHYDRAMINE CITRATE
20334 A II 2/23/2007 RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA DIPHENHYDRAMINE CITRATE
20572 A II 4/10/2007 WANBURY LTD DIPHENHYDRAMINE HYDROCHLORIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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