azithromycin

FDA Drug Profile — azithromycin, AZITHROMYCIN

Drug Details

Generic Name
azithromycin
Brand Names
azithromycin, AZITHROMYCIN
Application Number
ANDA065399
Sponsor
Major Pharmaceuticals
NDC Codes
18
Dosage Forms
TABLET, FILM COATED, POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients
AZITHROMYCIN DIHYDRATE, AZITHROMYCIN MONOHYDRATE

Indications and Usage

Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see DOSAGE AND ADMINISTRATION (2)]