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Last Updated: February 23, 2020

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Drug Master Files for: buspirone


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buspirone Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10414 I II 8/9/1993 ARCHIMICA SPA BUSPIRONE HYDROCHLORIDE
11148 A II 10/21/1994 FERMION OY BUSPIRONE HYDROCHLORIDE
11469 I II 4/12/1995 MEDICHEM SA BUSPIRONE HYDROCHLORIDE
12135 I II 9/16/1996 ALKALOIDA CHEMICAL CO ZRT BUSPIRONE BASE
12172 I II 10/16/1996 ALKALOIDA CHEMICAL CO ZRT BUSPIRONE HYDROCHLORIDE
12350 I II 2/3/1997 EGIS PHARMACEUTICALS PRIVATE LTD BUSPIRONE HYDROCHLORIDE USP BULK
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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