FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINE granules for oral solution
d101b5d8-bffc-4ee6-b93b-4589fcb8750d
HUMAN PRESCRIPTION DRUG LABEL
Jan 28, 2022
Cipla USA Inc.
DUNS: 078719707
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
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INGREDIENTS (6)
Drug Labeling Information
DESCRIPTION SECTION
DESCRIPTION
Fosfomycin tromethamine granules for oral solution contains fosfomycin tromethamine, a synthetic, broad spectrum, bactericidal antibiotic for oral administration. It is available as a single-dose sachet which contains white granules consisting of 5.631 grams of fosfomycin tromethamine (equivalent to 3 grams of fosfomycin), and the following inactive ingredients: mandarin flavor, orange powder flavor, saccharin, and sucrose. The contents of the sachet must be dissolved in water. Fosfomycin tromethamine, a phosphonic acid derivative, is available as (1R,2S)-(1,2-epoxypropyl)phosphonic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1). It is a white or almost white, hygroscopic powder with a molecular weight of 259.19. Its empirical formula is C3H7O4P.C4H11NO3, and its chemical structure is as follows:
