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Last Updated: December 14, 2019

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Drug Master Files for: mecamylamine

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mecamylamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13019 A II 6/12/1998 EUTICALS SPA MECAMYLAMINE BASE
14269 A II 7/6/1999 EUTICALS SPA MECAMYLAMINE HYDROCHLORIDE
21157 I II 12/17/2007 PRIME EUROPEAN THERAPEUTICS SPA (EUTICALS SPA) S(+)Mecamylamine Hydrochloride
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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