Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-9470Application Number
ANDA214554Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
September 1, 2022SACCHARINInactive
Code: FST467XS7DClass: IACT
FosfomycinActive
Code: 7FXW6U30GYClass: ACTIMQuantity: 3 g in 1 1
SUCROSEInactive
Code: C151H8M554Class: IACT
ORANGEInactive
Code: 5EVU04N5QUClass: IACT