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Last Updated: November 22, 2024

Drug Master Files for: sulfadiazine


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sulfadiazine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
11662 A II 9/15/1995 TEVA PHARMACEUTICAL INDUSTRIES LTD SILVER SULFADIAZINE
14757 I II 3/6/2000 DSM MINERA BV SILVER SULFADIAZINE
2013 I II 10/30/1972 MALLINCKRODT INC SILVER SULFADIAZINE
22083 A II 4/3/2008 AMISHI DRUGS AND CHEMICALS PVT LTD SILVER SULFADIAZINE USP
22692 I II 4/2/2009 SOUTHWEST SYNTHETIC PHARMACEUTICAL CORP LTD SULFADIAZINE
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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