Controls rapid ventricular rate in atrial flutter or atrial fibrillation except. ANDA 211370, held by Micro Labs. Verapamil Hydrochloride.
As of Nov 15, 2026, ANDA 211370 (Verapamil Hydrochloride), held by Micro Labs, was first approved by FDA on Dec 28, 2018, with 1 approved supplement 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 |
|---|---|---|---|
| Dec 28, 2018 | Original application | Approved | None posted |
| Verapamil Hydrochloride5MG/2ML (2.5MG/ML) · solution;intravenous | Verapamil Hydrochloride | Rx |
| Verapamil Hydrochloride10MG/4ML (2.5MG/ML) · solution;intravenous | Verapamil Hydrochloride | Rx |
| May 14, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Dec 28, 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
