Nebivolol Hydrochloride

Treats hypertension. ANDA 213830, held by Unichem. Nebivolol Hydrochloride.

As of Nov 15, 2026, ANDA 213830 (Nebivolol Hydrochloride), held by Unichem, was first approved by FDA on Mar 15, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Mar 15, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (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. 1.1 Hypertension

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Mar 15, 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 2 submissions, including labeling and manufacturing supplements


Aug 25, 2023	Supplement 4Labeling · Standard review	Approved	None posted
Mar 15, 2022	Original application	Approved	None posted

Identifiers

Application: ANDA 213830
Drugs@FDA: Overview at FDA
Company: Unichem Laboratories

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