For acute ingestion or from repeated supratherapeutic ingestion (RSI). ANDA 218397, held by Somerset Theraps LLC. Acetylcysteine.
As of Nov 15, 2026, ANDA 218397 (Acetylcysteine), held by Somerset Theraps LLC, was first approved by FDA on Jun 7, 2024, 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 patients with acute ingestion or from repeated supratherapeutic ingestion (RSI).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 7, 2024 | 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
