ANDA 214970, held by Medefil Inc. Atropine Sulfate.
As of Nov 15, 2026, ANDA 214970 (Atropine Sulfate), held by Medefil Inc, was first approved by FDA on Nov 4, 2022, with 0 approved supplements and 0 published complete response letters.
Atropine Sulfate Injection, USP, 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. These highlights do not include all the information needed to use ATROPINE SULFATE INJECTION safely and effectively. See full prescribing information for ATROPINE SULFATE INJECTION. ATROPINE SULFATE injection, for intravenous use Initial U.S. Approval: 1960
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| 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
