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Last Updated: November 25, 2024

Drug Master Files for: prednisolone tebutate


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prednisolone tebutate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11218 I II 10/7/1994 TIANJIN PHARMACEUTICAL CORP PREDNISOLONE
1432 I II 9/18/1969 PHARMACIA AND UPJOHN SUB PFIZER INC PREDNISOLONE USP
1454 I II 12/12/1969 UPJOHN CO FLUPREDNISOLONE & FLUPREDNISOLONE ACETATE
15652 I II 10/8/2001 SANOFI CHIMIE PREDNISOLONE SODIUM METASULFOBENZOATE
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
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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