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Drug Master Files for: buprenorphine

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DMF No. Status Type Submission Date Holder Subject
7099AII8/6/1987ASPEN OSS BVBUPRENORPHINE HYDROCHLORIDE AS MFG. IN OSS HOLLAND -
7343III2/18/1988MACFARLAN SMITHBUPRENORPHINE HYDROCHLORIDE MFG. IN EDINBURG, SCOTLAND
7684III9/16/1988SALARS SPABUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN COMO, ITALY.
7923III1/23/1989UNICHEM LABORATORIES LTDBUPRENORPHINE HYDROCHLORIDE MANUFACTURED IN BOMBAY, INDIA.
8542III4/27/1990DIOSYNTH BVBUPRENORPHINE AS MFG AK APELDOORN HOLLAND
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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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