ANDA 200880, held by Mylan Asi. Acetazolamide Sodium.
As of Nov 15, 2026, ANDA 200880 (Acetazolamide Sodium), held by Mylan Asi, was first approved by FDA on May 9, 2012, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 9, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide SodiumEQ 500MG BASE/VIAL · injectable;injection | Acetazolamide Sodium | Rx |
| May 7, 2026 | Supplement 15Labeling · Standard review | Approved | None posted |
| Aug 25, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| May 9, 2012 | Original application | Approved |
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
