ANDA 204797, held by Exela Pharma. Acetylcysteine.
As of Nov 15, 2026, ANDA 204797 (Acetylcysteine), held by Exela Pharma, was first approved by FDA on Apr 15, 2021, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine6GM/30ML (200MG/ML) ยท injectable;intravenous | Acetylcysteine | 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
