Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
078719707
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cipla Limited- Kurkumbh
Cipla USA Inc.
Cipla USA Inc.
917066446
Cipla USA Inc.
Cipla USA Inc.
463721500
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FOSFOMYCIN TROMETHAMINE
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
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:
