ANDA 200644, held by Fresenius Kabi USA. Acetylcysteine.
As of Nov 15, 2026, ANDA 200644 (Acetylcysteine), held by Fresenius Kabi USA, was first approved by FDA on Nov 7, 2012, with 1 approved supplement and 0 published complete response letters.
Acetylcysteine Injection is an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. Overdose incidences are divided into two types; Acute Ingestion or Repeated Supratherapeutic Ingestion (RSI).. On admission for suspected acetaminophen overdose, a serum blood sample should be drawn at least 4 hours after ingestion to determine the acetaminophen level and will serve as a basis for determining the need for treatment with acetylcysteine. If the patient presents after 4 hours post-ingestion, the serum acetaminophen sample should be determined immediately.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine6GM/30ML (200MG/ML) · injectable;intravenous | Acetylcysteine | Rx |
| Jan 10, 2016 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 7, 2012 | 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
