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Last Updated: January 21, 2020

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Drug Master Files for: CEFTRIAXONE SODIUM

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CEFTRIAXONE SODIUM Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13656 I II 9/1/1998 ROCHE PHARMACEUTICALS DIV HOFFMANN LAROCHE INC CEFTRIAXONE SODIUM
15931 A II 3/26/2002 LUPIN LTD CEFTRIAXONE SODIUM USP (STERILE )
16467 A II 3/12/2003 SANDOZ GMBH CEFTRIAXONE SODIUM (STERILE)
16650 A II 6/16/2003 WOCKHARDT LTD STERILE CEFTRIAXONE SODIUM USP
17257 A II 3/30/2004 ORCHID PHARMA LTD CEFTRIAXONE SODIUM
17259 A II 3/25/2004 ACS DOBFAR SPA CEFTRIAXONE SODIUM, USP (STERILE BULK)
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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