Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zambon Switzerland Ltd
Zambon USA, Ltd
481761344
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosfomycin Tromethamine
Product Details
NDC Product Code
82036-4274Application Number
NDA050717Marketing Category
NDA authorized generic (C73605)Route of Administration
ORALEffective Date
October 3, 2023ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SACCHARINInactive
Code: FST467XS7DClass: IACT
FosfomycinActive
Code: 7FXW6U30GYClass: ACTIMQuantity: 3 g in 1 1
TANGERINEInactive
Code: KH3E3096OOClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT