Treats poisoning. NDA 212319, held by Rafa Labs Ltd. Atropine.
As of Nov 14, 2026, NDA 212319 (Atropine (Autoinjector)), held by Rafa Labs Ltd, was first approved by FDA on Jul 9, 2018, with 2 approved supplements and 0 published complete response letters.
Atropine is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity as well as organophosphorus or carbamate insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2018 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine (Autoinjector)EQ 2MG SULFATE/0.7ML (EQ 2MG SULFATE/0.7ML) · solution;intramuscular | Atropine | Discontinued |
| Feb 27, 2023 | Supplement 7Labeling · Standard review | Approved | |
| Jul 9, 2019 | Supplement 2Labeling · Standard review | Approved | |
| Jul 9, 2018 | Original applicationNew formulation or manufacturer · Priority 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
