ANDA 204674, held by Alvogen. Acetylcysteine.
As of Nov 15, 2026, ANDA 204674 (Acetylcysteine), held by Alvogen, was first approved by FDA on Feb 11, 2014, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 11, 2014 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine10% ยท solution;inhalation, oral | Acetylcysteine | 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
