For acute ingestion or from repeated supratherapeutic ingestion (RSI). ANDA 207358, held by Eugia Pharma. Acetylcysteine.
As of Nov 15, 2026, ANDA 207358 (Acetylcysteine), held by Eugia Pharma, was first approved by FDA on Feb 29, 2016, with 1 approved supplement and 0 published complete response letters.
Acetylcysteine injection is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults and pediatric patients who weigh 5 kg or greater with acute ingestion or from repeated supratherapeutic ingestion (RSI).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine6GM/30ML (200MG/ML) · injectable;intravenous | Acetylcysteine | Rx |
| Dec 16, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 29, 2016 | 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
