Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alkem Laboratories Limited
Ascend Laboratories, LLC
677605851
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
67877-749Application Number
ANDA214554Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 1, 2022FosfomycinActive
Code: 7FXW6U30GYClass: ACTIMQuantity: 3 g in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
SACCHARINInactive
Code: FST467XS7DClass: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT