FOSFOMYCIN TROMETHAMINE
Fosfomycin Tromethamine Granules for Oral Solution Rx only
Approved
Approval ID
99becde1-fca5-4d82-8c3e-36ded62fc0d1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Granules for Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-5826
Application NumberANDA212548
Product Classification
M
Marketing Category
C73584
G
Generic Name
Granules for Oral
Product Specifications
Route of AdministrationORAL
Effective DateNovember 11, 2020
FDA Product Classification
INGREDIENTS (5)
FOSFOMYCIN TROMETHAMINEActive
Quantity: 3 g in 1 1
Code: 7FXW6U30GY
Classification: ACTIM
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TANGERINEInactive
Code: KH3E3096OO
Classification: IACT
SACCHARINInactive
Code: FST467XS7D
Classification: IACT