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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 217608

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NDA 217608 describes FOSFOMYCIN TROMETHAMINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Cipla, Precision Dose Inc, and Xiromed, and is included in six NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.

Summary for 217608

Tradename:	FOSFOMYCIN TROMETHAMINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	fosfomycin tromethamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 217608

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 217608

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	217608	ANDA	Aurobindo Pharma Limited	59651-651	59651-651-03	1 PACKET in 1 CARTON (59651-651-03) / 1 GRANULE, FOR SOLUTION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 3GM BASE/PACKET
Approval Date:	Nov 14, 2025	TE:	AA	RLD:	No

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