For acute ingestion or from repeated supratherapeutic ingestion (RSI). ANDA 213693, held by Glenmark Pharms. Acetylcysteine.
As of Nov 15, 2026, ANDA 213693 (Acetylcysteine), held by Glenmark Pharms, was first approved by FDA on Feb 3, 2022, with 0 approved supplements 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 3, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine6GM/30ML (200MG/ML) · injectable;intravenous | 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
