Controls rapid ventricular rate in atrial flutter or atrial fibrillation except. ANDA 214361, held by Gland. Verapamil Hydrochloride.
As of Nov 15, 2026, ANDA 214361 (Verapamil Hydrochloride), held by Gland, was first approved by FDA on Oct 15, 2020, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Verapamil Hydrochloride Injection, USP 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 |
|---|---|---|---|
| Oct 15, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Verapamil Hydrochloride2.5MG/ML · injectable;injection | Verapamil Hydrochloride | 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
