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Generated: September 22, 2019

DrugPatentWatch Database Preview

Drug Master Files for: efinaconazole

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efinaconazole Drug Master Files

DMF No. Status Type Submission Date Holder Subject
27081 A II 5/24/2013 KAKEN PHARMACEUTICAL CO LTD EFINACONAZOLE
30420 A II 3/30/2016 MAITHRI DRUGS PRIVATE LTD EFINACONAZOLE [ROUTE CODE 'EC']
30538 A II 5/31/2016 WAVELENGTH ENTERPRISES LTD EFINACONAZOLE
30892 A II 9/30/2016 GLENMARK PHARMACEUTICALS LTD EFINACONAZOLE
31366 A II 1/19/2017 VIRUPAKSHA ORGANICS LTD EFINACONAZOLE
31503 A II 4/14/2017 LUPIN LTD EFINACONAZOLE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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