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Generated: May 20, 2019

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Drug Master Files for: trimethobenzamide

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trimethobenzamide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
19965 I II 11/10/2006 FARCHEMIA SRL TRIMETHOBENZAMIDE HCI
26950 A II 6/11/2013 EMCURE PHARMACEUTICALS LTD TRIMETHOBENZAMIDE HYDROCHLORIDE USP
27428 I II 3/13/2014 DK PHARMA CHEM PVT LTD TRIMETHOBENZAMIDE HYDROCHLORIDE USP
4088 A II 2/27/1981 SIEGFRIED LTD TRIMETHOBENZAMIDE HCL.
4694 I II 10/14/1982 INDUSTRIA CHEMICA PRODOTTI FRANCIS SPA TRIMETHOBENZAMIDE HCL USP
7721 I II 10/20/1988 FABBRICA ITALIANA SINTETICI SPA TRIMETHOBENZAMIDE HYDROCHLORIDE
DMF No. Status Type Submission Date Holder Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
QuintilesIMS
McKesson
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Accenture
AstraZeneca

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