Bystolic

Treats hypertension. NDA 21742, held by Allergan. Nebivolol Hydrochloride.

As of Nov 15, 2026, NDA 21742 (Bystolic), held by Allergan, was first approved by FDA on Dec 17, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Dec 17, 2007
Review: Standard
Supplements approved: 10
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATIONS AND USAGE BYSTOLIC 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 11 submissions below


Feb 19, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 17, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Letter

Products

4 strengths and forms


BystolicEQ 2.5MG BASE · tablet;oral	Nebivolol Hydrochloride	RxReference drug
BystolicEQ 5MG BASE · tablet;oral	Nebivolol Hydrochloride	RxReference drug
BystolicEQ 10MG BASE · tablet;oral	Nebivolol Hydrochloride	RxReference drug
BystolicEQ 20MG BASE · tablet;oral	Nebivolol Hydrochloride	RxReference drug

All 11 submissions, including labeling and manufacturing supplements


Jun 16, 2023	Supplement 28Labeling · Standard review	Approved	Letter Label
Nov 30, 2017	Supplement 22Labeling · Standard review	Approved	Label Letter
Apr 20, 2015	Supplement 20Manufacturing · Standard review	Approved	None posted
Oct 30, 2014	Supplement 18Manufacturing · Standard review	Approved	None posted
Oct 27, 2014	Supplement 19Manufacturing · Standard review	Approved	None posted
Sep 20, 2013	Supplement 17Manufacturing · Standard review	Approved	None posted
Dec 19, 2012	Supplement 16Manufacturing · Standard review	Approved	None posted
Dec 14, 2011	Supplement 13Labeling	Approved	Letter Label
Feb 19, 2010	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 8, 2008	Supplement 3Manufacturing	Approved	None posted
Dec 17, 2007	Original applicationNew molecular entity · Standard review	Approved	Review Letter

Identifiers

Application: NDA 21742
Drugs@FDA: Overview at FDA
Company: Allergan

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