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Last Updated: October 7, 2024

Drug Master Files for: Guerbet


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Guerbet Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10121 I II 3/5/1993 GUERBET CHIMIE AULNAY SYNTHESIS OF P607 IN AULNAY SOUS BOIS, FRANCE.
11270 I II 12/27/1994 GUERBET CHIMIE AULNAY SA IOXITOL
2230 I II 2/4/1974 ANDRE GUERBET LABORATORIES IOCARMIC ACID
4495 I II 2/25/1982 LABORATORIE GUERBET IOXAGLIC ACID
4758 I II 12/20/1982 GUERBET IOXAGLIC ACID
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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