ANDA 217345, held by Hikma. Atropine Sulfate.
As of Nov 15, 2026, ANDA 217345 (Atropine Sulfate), held by Hikma, was first approved by FDA on Oct 24, 2025, 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 |
|---|---|---|---|
| Oct 24, 2025 | Original application | Approved | None posted |
| Atropine Sulfate0.4MG/ML (0.4MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Atropine Sulfate1MG/ML (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
