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Details for NDA: 075355

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NDA 075355 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apotex Inc, Apothecon, Eurohlth Intl, Gland Pharma Ltd, Hospira, Ivax Sub Teva Pharms, Mutual Pharm, Par Form, Sandoz, Teva, and Watson Labs, and is included in fourteen NDAs. Additional details are available on the LABETALOL HYDROCHLORIDE profile page.

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

Summary for NDA: 075355

Tradename:
LABETALOL HYDROCHLORIDE
Applicant:
Apothecon
Ingredient:
labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Glossary

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE; INJECTIONStrength5MG/ML
Approval Date:Nov 29, 1999TE:RLD:No


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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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