Last Updated: June 24, 2026

Details for New Drug Application (NDA): 075431

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NDA 075431 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Aiping Pharm Inc, Andas 5 Holding, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Macleods Pharms Ltd, Ph Health, Rubicon Research, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from forty-one suppliers. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.

The generic ingredient in LABETALOL HYDROCHLORIDE is labetalol hydrochloride. There are fourteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 075431

Tradename:	LABETALOL HYDROCHLORIDE
Applicant:	Rising
Ingredient:	labetalol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075431

Adrenergic alpha-1 Receptor Antagonists
Adrenergic beta-Antagonists
Antihypertensive Agents
Sympathomimetics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	5MG/ML
Approval Date:	Nov 29, 1999	TE:	AP	RLD:	No

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