Last Updated: May 3, 2026

Details for New Drug Application (NDA): 217772

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NDA 217772 describes FOSFOMYCIN TROMETHAMINE, which is a drug marketed by Alkem Labs Ltd, Amneal, Aucta, Aurobindo Pharma Ltd, Cipla, Precision Dose Inc, and Xiromed, and is included in seven 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 are six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.

Summary for 217772

Tradename:	FOSFOMYCIN TROMETHAMINE
Applicant:	Aucta
Ingredient:	fosfomycin tromethamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 217772

Anti-Bacterial Agents

Suppliers and Packaging for NDA: 217772

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	217772	ANDA	Aucta Pharmaceuticals, Inc.	73289-0067	73289-0067-1	1 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1)
FOSFOMYCIN TROMETHAMINE	fosfomycin tromethamine	FOR SOLUTION;ORAL	217772	ANDA	Aucta Pharmaceuticals, Inc.	73289-0067	73289-0067-2	1 DOSE PACK in 1 CARTON (73289-0067-2) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 3GM BASE/PACKET
Approval Date:	Apr 9, 2026	TE:	AA	RLD:	No

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