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Last Updated: December 22, 2024

Drug Master Files for: DIGOXIN


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DIGOXIN Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10067 I II 1/31/1993 PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO DIGOXIN DRUG SUBSTANCE
21559 A II 4/15/2008 BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG DIGOXIN 20 MICROMETER
2253 I II 3/28/1974 RP SCHERER CORP DIGOXIN CAPS
2277 I II 5/17/1974 ROCHE DIAGNOSTICS GMBH DIGOXIN PRODUCTS
24135 A II 8/16/2010 VITAL LABORATORIES PVT LTD DIGOXIN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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