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Last Updated: February 18, 2020

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Drug Master Files for: metronidazole


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metronidazole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16263 A II 11/18/2002 UNICHEM LABORATORIES LTD METRONIDAZOLE USP
16380 I II 1/16/2003 TIANJIN ZHONGAN PHARMACEUTICAL CO LTD METRONIDAZOLE
19442 I II 3/10/2006 HEC PHARM CO METRONIDAZOLE USP, NON-STERILE BULK FORM
2186 I II 11/15/1973 COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARL METRONIDAZOLE
23421 I II 12/30/2009 WUHAN WUYAO PHARMACEUTICAL CO LTD METRONIDAZOLE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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