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 |
33294 | A | II | 11/2/2018 | QUIMICA SINTETICA SA | FOSFOMYCIN TROMETHAMINE |
>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- Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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