Fosfomycin Tromethamine
Fosfomycin Tromethamine Granules for Oral Solution Rx only
Approved
Approval ID
fc25635d-7449-4853-8a6e-b5b4b53fbd03
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fosfomycin Tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9470
Application NumberANDA214554
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fosfomycin Tromethamine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2022
FDA Product Classification
INGREDIENTS (4)
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
FOSFOMYCIN TROMETHAMINEActive
Quantity: 3 g in 1 1
Code: 7FXW6U30GY
Classification: ACTIM
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT