Treats ocular conditions. ANDA 40001, held by Ani Pharms. Methazolamide.
As of Nov 15, 2026, ANDA 40001 (Methazolamide), held by Ani Pharms, was first approved by FDA on Jun 30, 1993, with 9 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 |
|---|---|---|---|
| Jun 30, 1993 | Original application | Approved | None posted |
| Methazolamide25MG · tablet;oral | Methazolamide | Rx |
| Methazolamide50MG · tablet;oral | Methazolamide | Rx |
| Dec 13, 2002 | Supplement 11Manufacturing | Approved | None posted |
| Nov 26, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Dec 7, 2000 | Supplement 9Manufacturing | Approved | None posted |
| Dec 7, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Dec 7, 2000 | Supplement 7Manufacturing | Approved | None posted |
| May 13, 1999 | Supplement 5Manufacturing | Approved | None posted |
| Mar 23, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Dec 7, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Aug 1, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Jun 30, 1993 | 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
