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Last Updated: March 28, 2024

Drug Master Files for: mefenamic acid


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mefenamic acid Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16491 A II 3/20/2003 WANBURY LTD MEFENAMIC ACID USP
18904 A II 9/21/2005 CHENG FONG CHEMICAL CO LTD MEFENAMIC ACID
19195 A II 2/23/2006 SOLARA A PHARMA SCIENCES LTD MEFENAMIC ACID, USP
20374 A II 3/21/2007 TAI HENG INDUSTRY CO LTD MEFENAMIC ACID USP
20778 I II 8/17/2007 TONIRA PHARMA LTD MEFENAMIC ACID
26589 A II 12/30/2013 WISDOM PHARMACEUTICAL CO LTD MEFENAMIC ACID
26771 I II 12/20/2012 SOUVIN PHARMACEUTICAL I PVT LTD MEFENAMIC ACID BP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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