ANDA 205358, held by Ph Health. Acetazolamide Sodium.
As of Nov 15, 2026, ANDA 205358 (Acetazolamide Sodium), held by Ph Health, was first approved by FDA on Jun 20, 2017, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 20, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetazolamide SodiumEQ 500MG BASE/VIAL ยท injectable;injection | Acetazolamide Sodium | Discontinued |
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
