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Generated: September 21, 2018

DrugPatentWatch Database Preview

Drug Master Files for: METHYLPREDNISOLONE SODIUM SUCCINATE

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METHYLPREDNISOLONE SODIUM SUCCINATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
15912 I II 3/25/2002 PHARMACIA AND UPJOHN SUB PFIZER INC METHYLPREDNISOLONE 100MG TABLETS
17547 A II 7/19/2004 TIANJIN TIANYAO PHARMACEUTICALS CO LTD METHYLPREDNISOLONE USP
18956 A II 1/5/2006 TIANJIN TIANYAO PHARMACEUTICALS CO LTD METHYLPREDNISOLONE ACETATE (BULK) USP
20310 A II 2/27/2007 TEVA PHARMACEUTICAL INDUSTRIES LTD METHYLPREDNISOLONE HEMISUCCINATE, BULK INTERMEDIATE
22575 A II 2/26/2009 NEWCHEM SPA METHYLPREDNISOLONE HEMISUCCINATE
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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
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Covington
Merck
Harvard Business School
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Fish and Richardson
McKinsey

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