Treats hypertension. ANDA 217397, held by Msn. Nebivolol Hydrochloride.
As of Nov 15, 2026, ANDA 217397 (Nebivolol Hydrochloride), held by Msn, was first approved by FDA on Oct 1, 2024, with 0 approved supplements and 0 published complete response letters.
Nebivolol tablets are a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. 1.1 Hypertension
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 1, 2024 | Original application | Approved | None posted |
| Nebivolol HydrochlorideEQ 2.5MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 5MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 10MG BASE · tablet;oral | Nebivolol Hydrochloride | Rx |
| Nebivolol HydrochlorideEQ 20MG BASE · tablet;oral | Nebivolol 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
