ANDA 211151, held by Ajanta Pharma Ltd. Acetazolamide.
As of Nov 13, 2026, ANDA 211151 (Acetazolamide), held by Ajanta Pharma Ltd, was first approved by FDA on Sep 11, 2023, with 2 approved supplements 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, USP 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 |
|---|---|---|---|
| Sep 11, 2023 | Original application | Approved | None posted |
| Acetazolamide125MG · tablet;oral | Acetazolamide | Discontinued |
| Acetazolamide250MG · tablet;oral | Acetazolamide | Discontinued |
| Jan 12, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 12, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Sep 11, 2023 | 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
