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FDA Approval

FOSFOMYCIN TROMETHAMINE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
November 24, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fosfomycin(3 g in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

A-S Medication Solutions

A-S Medication Solutions

830016429

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
50090-5826
Application Number
ANDA212548
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
November 11, 2020
Code: 7FXW6U30GYClass: ACTIMQuantity: 3 g in 1 1
ORANGEInactive
Code: 5EVU04N5QUClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TANGERINEInactive
Code: KH3E3096OOClass: IACT
SACCHARINInactive
Code: FST467XS7DClass: IACT
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