Labetalol Hydrochloride In Dextrose, Labetalol Hydrochloride In Sodium Chloride, Labetalol Hydrochloride

NDA 213330, held by Hikma. Labetalol Hydrochloride.

As of Nov 13, 2026, NDA 213330 (Labetalol Hydrochloride In Dextrose, Labetalol Hydrochloride In Sodium Chloride, Labetalol Hydrochloride), held by Hikma, was first approved by FDA on Nov 9, 2020, with 3 approved supplements and 0 published complete response letters.

First approved: Nov 9, 2020
Review: Standard
Supplements approved: 3
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Labetalol HCl Injection is indicated in severe hypertension, to lower blood pressure. Labetalol Hydrochloride (HCl) is a beta-adrenergic blocker.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below

Date	Submission	Status	Documents
Nov 9, 2020	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Products

6 strengths and forms

Product	Active ingredient	Marketing
Labetalol Hydrochloride In Dextrose200MG/200ML (1MG/ML) · solution;intravenous	Labetalol Hydrochloride	RxReference drug
Labetalol Hydrochloride In Sodium Chloride100MG/100ML (1MG/ML) · solution;intravenous	Labetalol Hydrochloride	RxReference drug
Labetalol Hydrochloride In Sodium Chloride200MG/200ML (1MG/ML) · solution;intravenous	Labetalol Hydrochloride	RxReference drug
Labetalol Hydrochloride In Sodium Chloride300MG/300ML (1MG/ML) · solution;intravenous	Labetalol Hydrochloride	RxReference drug
Labetalol Hydrochloride10MG/2ML (5MG/ML) · solution;intravenous	Labetalol Hydrochloride	DiscontinuedReference drug
Labetalol Hydrochloride20MG/4ML (5MG/ML) · solution;intravenous	Labetalol Hydrochloride	RxReference drug

All 4 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 19, 2024	Supplement 6Manufacturing	Approved	Label Letter
Jun 15, 2023	Supplement 5Labeling · Standard review	Approved	Label Letter
Mar 18, 2022	Supplement 3Manufacturing · Standard review	Approved	Letter Label
Nov 9, 2020	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 213330
Drugs@FDA: Overview at FDA
Company: Hikma

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