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Harvard Business School
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Last Updated: October 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: gabapentin

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gabapentin Drug Master Files

DMF No. Status Type Submission Date Holder Subject
12736 A II 11/12/1997 TEVA PHARMACEUTICAL INDUSTRIES LTD GABAPENTIN
13178 I II 9/4/1998 MEDICHEM SA GABAPENTIN, DRUG SUBSTANCE
14024 A II 3/19/1999 FIS FABBRICA ITALIANA SINTETICI SPA GABAPENTIN
15513 I II 7/3/2001 ERREGIERRE SPA GABAPENTIN
16060 A II 7/24/2002 HIKAL LTD GABAPENTIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving leading biopharmaceutical companies globally:

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