ANDA 219775, held by Gland. Acetazolamide Sodium.
As of Nov 15, 2026, ANDA 219775 (Acetazolamide Sodium), held by Gland, was first approved by FDA on Jun 17, 2025, with 0 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 17, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide SodiumEQ 500MG BASE/VIAL · injectable;injection | Acetazolamide Sodium | Rx |
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
