ANDA 211372, held by Somerset Theraps LLC. Acetazolamide.
As of Nov 13, 2026, ANDA 211372 (Acetazolamide), held by Somerset Theraps LLC, was first approved by FDA on Feb 22, 2021, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Feb 22, 2021 | Original application | Approved | None posted |
| Acetazolamide125MG · tablet;oral | Acetazolamide | Rx |
| Acetazolamide250MG · tablet;oral | Acetazolamide | Rx |
| Aug 16, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 22, 2021 | 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
