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Last Updated: November 21, 2024

Drug Master Files for: venlafaxine hydrochloride


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venlafaxine hydrochloride Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10005 I II 12/15/1992 ALZA CORP GITS (VENLAFAXINE HYDROCHLORIDE)
12346 A II 1/29/1997 ZACH SYSTEM SA VENLAFAXINE HYDROCHLORIDE
15923 A II 4/2/2002 SIEGFRIED LTD O-DESMETHYLVENLAFAXINE SUCCINATE MONOHYDRATE
16084 I II 8/5/2002 MEDICHEM SA VENLAFAXINE HCL
16188 A II 10/4/2002 UQUIFA MEXICO SA DE CV VENLAFAXINE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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