NDA 21146, held by Hospira. Atropine Sulfate.
As of Nov 14, 2026, NDA 21146 (Atropine Sulfate), held by Hospira, was first approved by FDA on Jul 9, 2001, with 8 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2001 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Atropine Sulfate0.5MG/5ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | RxReference drug |
| Atropine Sulfate0.25MG/5ML (0.05MG/ML) · solution;intravenous | Atropine Sulfate | RxReference drug |
| Atropine Sulfate1MG/10ML (0.1MG/ML) · solution;intravenous | Atropine Sulfate | RxReference drug |
| Jul 30, 2025 | Supplement 37Labeling · Standard review | Approved | |
| Nov 30, 2020 | Supplement 25Manufacturing | Approved | |
| Jun 24, 2020 | Supplement 22Labeling · Standard review | Approved | |
| Nov 1, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Aug 17, 2017 | Supplement 18Manufacturing | Approved | |
| Jan 31, 2017 | Supplement 16Labeling · Standard review | Approved | |
| Oct 30, 2015 | Supplement 15Labeling · Standard review | Approved | |
| Mar 12, 2014 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Jul 9, 2001 | Original applicationNew formulation or manufacturer · Standard review | 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
