ANDA 211317, held by Carlsbad. Azithromycin.
As of Nov 13, 2026, ANDA 211317 (Azithromycin), held by Carlsbad, was first approved by FDA on Jul 26, 2022, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 26, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| AzithromycinEQ 250MG BASE ยท tablet;oral | Azithromycin | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 23, 2024 | Supplement 2Manufacturing | Approved | None posted |
| Jul 26, 2022 | 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
