Nebivolol Hydrochloride

Treats hypertension. ANDA 212682, held by Prinston. Nebivolol Hydrochloride.

As of Nov 15, 2026, ANDA 212682 (Nebivolol Hydrochloride), held by Prinston, was first approved by FDA on Apr 7, 2022, with 2 approved supplements and 0 published complete response letters.

First approved: Apr 7, 2022
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE Nebivolol is 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Apr 7, 2022	Original application	Approved	None posted

Products

4 strengths and forms


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

All 3 submissions, including labeling and manufacturing supplements


May 20, 2026	Supplement 3Labeling · Standard review	Approved	None posted
Nov 2, 2022	Supplement 1Labeling · Standard review	Approved	None posted
Apr 7, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 212682
Drugs@FDA: Overview at FDA
Company: Prinston Pharmaceutical

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