NDA 21539, held by Apotex. Acetylcysteine.
As of Nov 14, 2026, NDA 21539 (Acetadote), held by Apotex, was first approved by FDA on Jan 23, 2004, with 13 approved supplements and 0 published complete response letters.
| Nov 26, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Jan 23, 2004 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetadote6GM/30ML (200MG/ML) · injectable;intravenous | Acetylcysteine | RxReference drug |
| Jul 23, 2025 | Supplement 21Labeling · Standard review | Approved | |
| Nov 26, 2024 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Sep 27, 2021 | Supplement 20Labeling · Standard review | Approved | |
| Oct 30, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Jan 23, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Jul 29, 2016 | Supplement 15Labeling · Standard review | Approved | |
| Jun 5, 2013 | Supplement 12Labeling | Approved | |
| Jan 15, 2013 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Jan 7, 2011 | Supplement 10Manufacturing · Priority review | Approved | None posted |
| Dec 12, 2008 | Supplement 5Labeling · Standard review | Approved | |
| Feb 15, 2006 | Supplement 4Labeling · Standard review | Approved | |
| Apr 28, 2004 | Supplement 2Labeling · Standard review | Approved | |
| Apr 28, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Jan 23, 2004 | Original applicationNew dosage form · Priority review | 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
