Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 211792, held by Alembic. Azithromycin.
As of Nov 13, 2026, ANDA 211792 (Azithromycin), held by Alembic, was first approved by FDA on Jan 28, 2020, with 2 approved supplements and 0 published complete response letters.
Azithromycin tablets are 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 |
|---|---|---|---|
| Jan 28, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 500MG BASE · tablet;oral | Azithromycin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 13, 2022 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jun 4, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 28, 2020 | 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
