Last Updated: September 24, 2026

Details for New Drug Application (NDA): 210426

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NDA 210426 describes FOSFOMYCIN TROMETHAMINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Aucta, Aurobindo Pharma Ltd, Cipla, Novitium Pharma, Precision Dose Inc, and Xiromed, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the FOSFOMYCIN TROMETHAMINE profile page.

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

Summary for 210426

Tradename:	FOSFOMYCIN TROMETHAMINE
Applicant:	Novitium Pharma
Ingredient:	fosfomycin tromethamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 210426

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 3GM BASE/PACKET
Approval Date:	Aug 12, 2026	TE:	AA	RLD:	No

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