Controls rapid ventricular rate in atrial flutter or atrial fibrillation except. ANDA 210994, held by Amneal. Verapamil Hydrochloride.
As of Nov 15, 2026, ANDA 210994 (Verapamil Hydrochloride), held by Amneal, was first approved by FDA on Jul 13, 2018, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Verapamil hydrochloride injection is indicated for the following: Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [W-P-W] and Lown-Ganong- Levine [L-G-L] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to verapamil hydrochloride administration.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 13, 2018 | Original application | Approved | None posted |
| Verapamil Hydrochloride5MG/2ML (2.5MG/ML) · solution;intravenous | Verapamil Hydrochloride | Discontinued |
| Verapamil Hydrochloride10MG/4ML (2.5MG/ML) · solution;intravenous | Verapamil Hydrochloride | Discontinued |
| Sep 19, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 13, 2018 | Original application | Approved | None posted |
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
