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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Daiichi Sankyo
US Department of Justice

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075240

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NDA 075240 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by Akorn Inc, Apothecon, Baxter Hlthcare Corp, Gland Pharma Ltd, Hospira, Mylan Asi, West-ward Pharms Int, Innogenix, Ivax Sub Teva Pharms, Par Form, Sandoz, Teva, Watson Labs, and Zydus Pharms Usa Inc, and is included in eighteen NDAs. It is available from thirty 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. Thirty-four suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 075240
Ingredient:labetalol hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075240
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075240
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075240 ANDA Hospira, Inc. 0409-2267 N 0409-2267-20
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075240 ANDA Hospira, Inc. 0409-2267 N 0409-2267-54

Profile for product number 001

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

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Argus Health

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