ANDA 210588, held by Novitium Pharma. Acetazolamide.
As of Nov 13, 2026, ANDA 210588 (Acetazolamide), held by Novitium Pharma, was first approved by FDA on Oct 17, 2019, with 3 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE For adjunctive treatment of: edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acetazolamide Tablets are also indicated for the prevention or amelioration of symptoms associated with acute mountain sickness in climbers attempting rapid ascent and in those who are very susceptible to acute mountain sickness despite gradual ascent.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 17, 2019 | Original application | Approved | None posted |
| Acetazolamide125MG · tablet;oral | Acetazolamide | Rx |
| Acetazolamide250MG · tablet;oral | Acetazolamide | Rx |
| Apr 2, 2026 | Supplement 18Labeling · Standard review | Approved | None posted |
| Mar 13, 2025 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 9, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 17, 2019 | 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
