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Generated: September 16, 2019

DrugPatentWatch Database Preview

Drug Master Files for: fingolimod

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fingolimod Drug Master Files

DMF No. Status Type Submission Date Holder Subject
26401 A II 11/5/2012 DR REDDYS LABORATORIES LTD FINGOLIMOD HYDROCHLORIDE
26807 A II 2/20/2013 GLENMARK PHARMACEUTICALS LTD FINGOLIMOD HYDROCHLORIDE
27730 A II 12/17/2013 MYLAN LABORATORIES LTD FINGOLIMOD HYDROCHLORIDE USP
>DMF No. >Status >Type >Submission Date >Holder >Subject

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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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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