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Last Updated: November 2, 2024

Drug Master Files for: OXYBUTYNIN CHLORIDE


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OXYBUTYNIN CHLORIDE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11478 I II 4/27/1995 SELOC AG OXYBUTYNIN BASE
11947 A II 4/26/1996 SIEGFRIED EVIONNAZ SA OXYBUTYNIN BASE
12309 A II 1/9/1997 CORDEN PHARMA CHENOVE OXYBUTYNIN HYDROCHLORIDE
12840 I II 2/2/1998 SANOFI AVENTIS SPA OXYBUTYNIN CHLORIDE
13084 A II 7/22/1998 PCAS OXYBUTYNIN BASE
14071 I II 3/30/1999 JUZEN CHEMICAL CORP OXYBUTYNIN
16061 I II 7/22/2002 WOCKHARDT BIO AG OXYBUTYNIN CHLORIDE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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