ANDA 202693, held by Avet Lifesciences. Acetazolamide Sodium.
As of Nov 15, 2026, ANDA 202693 (Acetazolamide Sodium), held by Avet Lifesciences, was first approved by FDA on Dec 19, 2014, with 3 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 is 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 |
|---|---|---|---|
| Dec 19, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide SodiumEQ 500MG BASE/VIAL · injectable;injection | Acetazolamide Sodium | Rx |
| Jun 5, 2026 | Supplement 12Labeling · Standard review | Approved | None posted |
| Jul 26, 2024 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 26, 2024 | Supplement 7Labeling · Standard review | Approved | None posted |
| Dec 19, 2014 | 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
