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Generated: December 12, 2018

DrugPatentWatch Database Preview

Drug Master Files for: HYDROCORTISONE VALERATE

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HYDROCORTISONE VALERATE Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10447 I II 8/26/1993 PHARMACIA AND UPJOHN SUB PFIZER INC HYDROCORTISONE BUTYRATE
11606 A II 7/27/1995 SHANDONG XINHUA PHARMACEUTICAL CO LTD HYDROCORTISONE
117 I II 9/11/1953 PASADENA RESEARCH LABORATORIES INC HYDROCORTISONE ACETATE
13921 A II 12/30/1998 TARO PHARMACEUTICAL INDUSTRIES LTD HYDROCORTISONE 17-VALERATE, USP
1413 A II 9/2/1969 PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INC HYDROCORTISONE MICRONIZED AND NON-MICRONIZED
15750 A II 12/6/2001 TARO PHARMACEUTICAL INDUSTRIES LTD HYDROCORTISONE 17-BUTYRATE, USP
16089 A II 8/6/2002 HIKMA PHARMACEUTICALS HYDROCORTISONE 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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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