ANDA 207401, held by Micro Labs Ltd India. Acetazolamide.
As of Nov 13, 2026, ANDA 207401 (Acetazolamide), held by Micro Labs Ltd India, was first approved by FDA on Oct 1, 2020, 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 |
|---|---|---|---|
| Oct 1, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide500MG · capsule, extended release;oral | Acetazolamide | Rx |
| Nov 26, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 19, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 1, 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
