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Last Updated: March 28, 2024

Drug Master Files for: fosfomycin tromethamine


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fosfomycin tromethamine Drug Master Files

DMF No. Status Type Submission Date Holder Subject
10891 A II 4/28/1994 FIS FABBRICA ITALIANA SINTETICI SPA FOSFOMYCIN TROMETAMOL
11582 A II 7/10/1995 ERCROS SA FOSFOMYCIN PHENYLAMMONIUM SALT
14341 A II 8/4/1999 ERCROS SA FOSFOMYCIN SODIUM
31195 A II 2/24/2017 ERCROS SA FOSFOMYCIN TROMETHAMINE
31656 A II 4/4/2017 INTERQUIM SA DE CV FOSFOMYCIN TROMETAMOL (TROMETHAMINE) PH EUR/USP
>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  • Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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