ANDA 215342, held by Amneal. Atropine Sulfate.
As of Nov 15, 2026, ANDA 215342 (Atropine Sulfate), held by Amneal, was first approved by FDA on Jan 26, 2022, with 0 approved supplements and 0 published complete response letters.
Atropine sulfate injection is indicated for temporary blockade of severe or life-threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus or muscarinic mushroom poisoning and to treat bradyasystolic cardiac arrest.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 2022 | Original application | Approved |
| Atropine Sulfate0.5MG/5ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Atropine Sulfate1MG/10ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | 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
