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Last Updated: March 31, 2020

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Drug Master Files for: cefazolin sodium


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cefazolin sodium Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10129 I II 11/18/1988 BIOCHIMICA OPOS 2 SPA CEFAZOLIN FREE ACID
10130 I II 7/31/1986 BIOCHIMICA OPOS 2 SPA CEFAZOLIN SODIUM, BULK
10152 I V 8/7/1972 ASTELLAS PHARMA INC STERILE PROCESSING FACILITIES FOR CEFAZOLIN SODIUM STERILE, (BULK) AS LOCATED IN FUJI, JAPAN
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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