ANDA 210423, held by Alembic. Acetazolamide.
As of Nov 13, 2026, ANDA 210423 (Acetazolamide), held by Alembic, was first approved by FDA on Feb 19, 2019, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: For adjunctive treatment of: chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide extended-release capsules are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 19, 2019 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide500MG · capsule, extended release;oral | Acetazolamide | Rx |
| Dec 12, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Feb 19, 2019 | 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
