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Details for New Drug Application (NDA): 075355

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NDA 075355 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Eurohlth Intl Sarl, Par Form, Sandoz, Nostrum Labs Inc, Apothecon, Akorn Inc, Watson Labs, Sagent Strides, Hospira, Claris, Ivax Sub Teva Pharms, Teva, and Gland Pharma Ltd, and is included in seventeen NDAs. It is available from twenty-nine suppliers. 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. Thirty-one 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
Formulation / Manufacturing:see details

Summary for product number 001

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


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