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Last Updated: March 28, 2024

Drug Master Files for: ferric citrate


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ferric citrate Drug Master Files

DMF No. Status Type Submission Date Holder Subject
16056 A II 7/22/2002 PANION AND BF BIOTECH INC FERRIC CITRATE
17602 I II 8/13/2004 CILAG AG SODIUM FERRIC GLUCONATE
17645 I II 8/30/2004 OPOCRIN SPA SODIUM FERRIC GLUCONATE
17746 A II 10/7/2004 BIOFER SPA SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
18541 A II 7/29/2005 NAVINTA LLC SODIUM FERRIC GLUCONATE COMPLEX
21983 I II 9/17/2008 EMCURE PHARMACEUTICALS LTD SODIUM FERRIC GLUCONATE COMPLEX
28175 A II 5/15/2014 PAR PHARMACEUTICAL INC FERRIC CITRATE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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