Treats mild to moderate infections caused by susceptible strains of the designated…. ANDA 211791, held by Alembic. Azithromycin.
As of Nov 14, 2026, ANDA 211791 (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 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 populations vary in these indications.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 250MG BASE · tablet;oral | Azithromycin | Rx |
| 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
