ANDA 212461, held by Intl Medication Sys. Atropine Sulfate.
As of Nov 15, 2026, ANDA 212461 (Atropine Sulfate), held by Intl Medication Sys, was first approved by FDA on Oct 5, 2020, with 1 approved supplement 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 5, 2020 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate1MG/10ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Apr 8, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Oct 5, 2020 | 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
