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Last Updated: December 11, 2024

Details for New Drug Application (NDA): 075355

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NDA 075355 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Apothecon, Baxter Hlthcare Corp, Caplin, Gland Pharma Ltd, Hikma, Hospira, Rising, Steriscience Speclts, Andas 5 Holding, Appco, Cadila Pharms Ltd, Endo Operations, Epic Pharma Llc, Heritage Pharma, Hibrow Hlthcare, Rubicon, Sandoz, Teva, Unichem, Watson Labs, and Zydus Pharms, and is included in twenty-six NDAs. It is available from forty 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 suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for 075355

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

Medical Subject Heading (MeSH) Categories for 075355

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

Profile for product number 001

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

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