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Last Updated: August 7, 2020

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Drug Master Files for: FELBAMATE

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FELBAMATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
20438 I II 4/12/2007 APICORE US LLC FELBAMATE
21247 A II 1/14/2008 PROCOS SPA FELBAMATE
22201 I II 11/20/2008 HETERO DRUGS LTD FELBAMATE
22810 A II 6/15/2009 SOLARA A PHARMA SCIENCES LTD FELBAMATE
22958 A II 7/15/2009 APICORE US LLC FELBAMATE USP
27331 A II 11/5/2013 TARO PHARMACEUTICAL INDUSTRIES LTD FELBAMATE USP
28661 A II 11/23/2015 ENALTEC LABS PRIVATE LTD FELBAMATE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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