Drug Master Files for: FOSFOMYCIN TROMETHAMINE

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FOSFOMYCIN TROMETHAMINE Drug Master Files

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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
>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Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)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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