ANDA 215005, held by Somerset Theraps LLC. Atropine Sulfate.
As of Nov 15, 2026, ANDA 215005 (Atropine Sulfate), held by Somerset Theraps LLC, was first approved by FDA on Nov 29, 2024, with 0 approved supplements and 0 published complete response letters.
Atropine is indicated for temporary blockade of severe or life threatening muscarinic effects, e.g., as an antisialagogue, an antivagal agent, an antidote for organophosphorus, carbamate, or muscarinic mushroom poisoning, and to treat symptomatic bradycardia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 29, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atropine Sulfate8MG/20ML (0.4MG/ML) · solution;intravenous, intramuscular, subcutaneous, intraosseous, endotracheal | 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
