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Generated: September 22, 2019

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Drug Master Files for: tavaborole

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tavaborole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
31283 A II 1/31/2017 GLENMARK PHARMACEUTICALS LTD TAVABOROLE
31431 A II 3/2/2017 BIOPHORE INDIA PHARMACEUTICALS PVT LTD TAVABOROLE
32083 A II 3/26/2018 TARO PHARMACEUTICAL INDUSTRIES LTD TAVABOROLE
32154 A II 10/30/2017 MSN LIFE SCIENCES PRIVATE LTD TAVABOROLE
32315 A II 12/31/2017 WAVELENGTH ENTERPRISES LTD TAVABOROLE
32533 A II 4/27/2018 HONOUR LAB LTD TAVABOROLE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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