NDA 209260, held by Fresenius Kabi USA. Atropine Sulfate.
As of Nov 13, 2026, NDA 209260 (Atropine Sulfate), held by Fresenius Kabi USA, was first approved by FDA on Jan 26, 2018, with 0 approved supplements and 0 published complete response letters.
Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate8MG/20ML (0.4MG/ML) · solution;intravenous, intramuscular, subcutaneous, intraosseous, endotracheal | Atropine Sulfate | RxReference drug |
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
