Controls rapid ventricular rate in atrial flutter or atrial fibrillation except. ANDA 211015, held by Somerset Theraps LLC. Verapamil Hydrochloride.
As of Nov 15, 2026, ANDA 211015 (Verapamil Hydrochloride), held by Somerset Theraps LLC, was first approved by FDA on Jun 18, 2018, with 4 approved supplements and 0 published complete response letters.
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. Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White (W-P-W) and Lown-Ganong-Levine (L-G-L) syndromes).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 18, 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 20, 2026 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 2Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jun 18, 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
