Treats ocular conditions. ANDA 207438, held by Bausch And Lomb Inc. Methazolamide.
As of Nov 15, 2026, ANDA 207438 (Methazolamide), held by Bausch And Lomb Inc, was first approved by FDA on Oct 5, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Methazolamide tablets are 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 5, 2018 | 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
