ANDA 207503, held by Breckenridge. Acetazolamide.
As of Nov 13, 2026, ANDA 207503 (Acetazolamide), held by Breckenridge, was first approved by FDA on Apr 30, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 30, 2020 | Original application | Approved | None posted |
| Acetazolamide125MG · tablet;oral | Acetazolamide | Discontinued |
| Acetazolamide250MG · tablet;oral | Acetazolamide | Discontinued |
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
