ANDA 40784, held by Xgen Pharms. Acetazolamide Sodium.
As of Nov 15, 2026, ANDA 40784 (Acetazolamide Sodium), held by Xgen Pharms, was first approved by FDA on Dec 10, 2008, 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 |
|---|---|---|---|
| Dec 10, 2008 | 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
