Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 209201, held by Aurobindo Pharma Ltd. Azithromycin.
As of Nov 13, 2026, ANDA 209201 (Azithromycin), held by Aurobindo Pharma Ltd, was first approved by FDA on Oct 9, 2018, with 3 approved supplements and 0 published complete response letters.
Azithromycin for oral suspension is a macrolide antibacterial drug indicated for treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: Acute bacterial exacerbations of chronic bronchitis in adults Acute bacterial sinusitis in adults Uncomplicated skin and skin structure infections in adults Urethritis and cervicitis in adults Genital ulcer disease in men Acute otitis media in pediatric patients (6 months of age and older) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1, 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 100MG BASE/5ML · for suspension;oral | Azithromycin | Rx |
| AzithromycinEQ 200MG BASE/5ML · for suspension;oral | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 18, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 23, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 9, 2018 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
