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Last Updated: November 15, 2024

Drug Master Files for: CEFTAZIDIME


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CEFTAZIDIME Drug Master Files

DMF No. Status Type Submission Date Holder Subject
13009 A II 5/25/1998 SANDOZ GMBH CTAZ.DH (=CEFTAZIDIME DIHYDROCHLORIDE)
13650 I II 8/10/2000 GLAXO WELLCOME INC CEFTAZIDIME PENTAHYDRATE BULK DRUG SUBSTANCE
13683 A II 9/1/1998 ACS DOBFAR SPA CEFTAZIDIME FOR INJECTION (CEFTAZIDIME STERILE BUFFERED)
16082 A II 8/6/2002 SANDOZ GMBH CEFTAZIDIME FOR INJECTION
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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