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Last Updated: December 26, 2024

Drug Master Files for: oseltamivir phosphate


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oseltamivir phosphate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
21557 A II 5/29/2008 CIPLA LTD OSELTAMIVIR PHOSPHATE USP
22926 A II 7/8/2009 SOLARA A PHARMA SCIENCES LTD OSELTAMIVIR PHOSPHATE
23889 A II 6/15/2010 MSN PHARMACHEM PRIVATE LTD OSELTAMIVIR PHOSPHATE [ROUTE CODE - OT]
27533 A II 9/29/2013 MACLEODS PHARMACEUTICALS LTD OSELTAMIVIR PHOSPHATE
30012 A II 11/30/2015 MYLAN LABORATORIES LTD OSELTAMIVIR PHOSPHATE USP
30253 A II 4/13/2016 LUPIN LTD OSELTAMIVIR PHOSPHATE USP
30412 A II 3/16/2016 HETERO LABS LTD OSELTAMIVIR PHOSPHATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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