NDA 12945, held by Teva Branded Pharm. Acetazolamide.
As of Nov 14, 2026, NDA 12945 (Diamox), held by Teva Branded Pharm, was first approved by FDA on Jan 25, 1962, with 9 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 25, 1962 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diamox500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Acetazolamide | DiscontinuedReference drug |
| Sep 20, 2024 | Supplement 48Labeling · Standard review | Approved | |
| May 13, 2022 | Supplement 47Labeling · Standard review | Approved | |
| Apr 9, 2014 | Supplement 46Manufacturing | Approved | None posted |
| Mar 19, 2014 | Supplement 45Manufacturing | Approved | None posted |
| Mar 15, 2005 | Supplement 37Manufacturing | Approved | |
| Mar 15, 2005 | Supplement 38Labeling · Standard review | Approved | |
| Jul 21, 2003 | Supplement 34Labeling · Standard review | Approved | None posted |
| Sep 27, 1999 | Supplement 30Manufacturing | Approved | None posted |
| Apr 25, 1995 | Supplement 28Manufacturing | Approved | None posted |
| Jan 25, 1962 | Original applicationNew formulation or manufacturer · Standard review | 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
