Fosfomycin Tromethamine
Granules for Oral Solution Rx only
Approved
Approval ID
ca668546-c8ba-af0a-e053-2995a90a2300
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 3, 2023
Manufacturers
FDA
Zambon USA, Ltd
DUNS: 118086168
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 Code82036-4274
Application NumberNDA050717
Product Classification
M
Marketing Category
C73605
G
Generic Name
Fosfomycin Tromethamine
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2023
FDA Product Classification
INGREDIENTS (5)
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT
FOSFOMYCIN TROMETHAMINEActive
Quantity: 3 g in 1 1
Code: 7FXW6U30GY
Classification: ACTIM
TANGERINEInactive
Code: KH3E3096OO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT