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LABETALOL HYDROCHLORIDE

NDA · New Drug Application · Sponsor: HIKMA · Approved 2020-11-09

Drug application

FDA Application #

NDA213330

Application type

New Drug Application

Brand name

LABETALOL HYDROCHLORIDE

Generic name

LABETALOL HYDROCHLORIDE

Active ingredients

LABETALOL HYDROCHLORIDE

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Discontinued

Sponsor

HIKMA

Manufacturer

Hikma Pharmaceuticals USA Inc.

First approval

2020-11-09

Source

Authoritative

Drugs@FDA application overview

Machine

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