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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 075113

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NDA 075113 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Amneal, Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Onesource Specialty, Rising, Andas 5 Holding, Appco, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Macleods Pharms Ltd, Ph Health, Rubicon Research, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from forty-three 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-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 075113

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

Medical Subject Heading (MeSH) Categories for 075113

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 4, 1998	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Aug 4, 1998	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	300MG
Approval Date:	Aug 4, 1998	TE:	AB	RLD:	No

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