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Serving hundreds of leading biopharmaceutical companies globally:

US Army
UBS
AstraZeneca
Merck
Covington
Julphar
Cipla
Johnson and Johnson
Federal Trade Commission

Generated: May 26, 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-one 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-five suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 075240
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Hospira
Ingredient:labetalol hydrochloride
Patents:0
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:

Harvard Business School
Cipla
Chubb
Express Scripts
Merck
Farmers Insurance
Federal Trade Commission
Cerilliant
McKinsey

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