ANDA 212868, held by Accord Hlthcare. Atropine Sulfate.
As of Nov 15, 2026, ANDA 212868 (Atropine Sulfate), held by Accord Hlthcare, was first approved by FDA on Jul 26, 2021, with 3 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 |
|---|---|---|---|
| Jul 26, 2021 | Original application | Approved |
| Atropine Sulfate0.25MG/5ML (0.05MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Atropine Sulfate0.5MG/5ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Atropine Sulfate1MG/10ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | Rx |
| Mar 18, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Apr 7, 2023 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 23, 2022 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 26, 2021 | 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
