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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 217187

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NDA 217187 describes FOSFOMYCIN TROMETHAMINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Cipla, Precision Dose Inc, and Xiromed, and is included in five NDAs. It is available from six suppliers. Additional details are available on the FOSFOMYCIN TROMETHAMINE profile page.

The generic ingredient in FOSFOMYCIN TROMETHAMINE is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.

Summary for 217187

Tradename:	FOSFOMYCIN TROMETHAMINE
Applicant:	Precision Dose Inc
Ingredient:	fosfomycin tromethamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 217187

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 3GM BASE/PACKET
Approval Date:	Jun 3, 2025	TE:	AA	RLD:	No

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