Treats ocular conditions. ANDA 215615, held by Tagi. Methazolamide.
As of Nov 15, 2026, ANDA 215615 (Methazolamide), held by Tagi, was first approved by FDA on Oct 18, 2022, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methazolamide Tablets, USP is indicated in the treatment of ocular conditions where lowering intraocular pressure is likely to be of therapeutic benefit, such as chronic open-angle glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where lowering the intraocular pressure is desired before surgery.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 2022 | Original application | Approved | None posted |
| Methazolamide25MG · tablet;oral | Methazolamide | Rx |
| Methazolamide50MG · tablet;oral | Methazolamide | Rx |
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
