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Last Updated: December 26, 2024

Drug Master Files for: pimozide


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pimozide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10872 I II 4/18/1994 JANSSEN RESEARCH FDN PIMOZIDE
22747 A II 4/23/2009 UNIMARK REMEDIES LTD PIMOZIDE USP [-2]
25462 A II 12/14/2011 PAR PHARMACEUTICAL INC PIMOZIDE USP
27583 A II 10/21/2013 VASUDHA PHARMA CHEM LTD PIMOZIDE USP
28495 A II 10/31/2014 SAI LIFE SCIENCES LTD PIMOZIDE USP
8426 I II 2/1/1990 NV ORGANON PIMOZIDE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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