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Last Updated: March 19, 2026

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, 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 217187

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

Medical Subject Heading (MeSH) Categories for 217187

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 217187

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	217187	ANDA	Precision Dose, Inc.	68094-064	68094-064-20	1 PACKET in 1 CARTON (68094-064-20) / 1 GRANULE in 1 PACKET (68094-064-01)

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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