ANDA 203434, held by Novast Labs. Acetazolamide.
As of Nov 13, 2026, ANDA 203434 (Acetazolamide), held by Novast Labs, was first approved by FDA on Sep 30, 2016, with 1 approved supplement 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 is also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness despite gradual ascent.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide500MG · capsule, extended release;oral | Acetazolamide | Rx |
| Jun 6, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 30, 2016 | Original application | Approved |
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
