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Last Updated: December 12, 2019

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Drug Master Files for: dofetilide

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dofetilide Drug Master Files

DMF No. Status Type Submission Date Holder Subject
27816 A II 2/25/2014 JOHNSON MATTHEY PHARMA SERVICES 4245.C (MILLED) [DOFETILIDE]
28301 A II 6/5/2014 SIGMAPHARM LABORATORIES LLC AMORPHOUS DOFETILIDE
29722 A II 10/7/2015 APICORE US LLC DOFETILIDE USP, POLYMORPH P162B
30042 A II 12/17/2015 INDUSTRIALE CHIMICA SRL DOFETILIDE USP
30508 A II 6/29/2016 BIDDLE SAWYER PHARMA LLC DOFETILIDE USP
30560 A II 6/1/2016 AUROBINDO PHARMA LTD DOFETILIDE USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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