ANDA 218023, held by Epic Pharma LLC. Acetazolamide.
As of Nov 13, 2026, ANDA 218023 (Acetazolamide), held by Epic Pharma LLC, was first approved by FDA on May 14, 2024, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 14, 2024 | Original application | Approved | None posted |
| Acetazolamide125MG · tablet;oral | Acetazolamide | Rx |
| Acetazolamide250MG · tablet;oral | Acetazolamide | Rx |
| Sep 30, 2026 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 14, 2024 | 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
