ANDA 207659, held by Accord Hlthcare. Acetazolamide.
As of Nov 13, 2026, ANDA 207659 (Acetazolamide), held by Accord Hlthcare, was first approved by FDA on Oct 18, 2018, with 3 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 |
|---|---|---|---|
| Oct 18, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide500MG · capsule, extended release;oral | Acetazolamide | Rx |
| Jan 27, 2025 | Supplement 7Labeling · Standard review | Approved | None posted |
| Mar 21, 2024 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 19, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 18, 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
