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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Cerilliant
US Army
Colorcon
AstraZeneca
UBS
Julphar
Deloitte
Moodys

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075215

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NDA 075215 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 twenty-seven 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 suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 075215
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Innogenix
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075215
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075215
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075215 ANDA Marlex Pharmaceuticals Inc 10135-641 N 10135-641-01
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075215 ANDA Marlex Pharmaceuticals Inc 10135-642 N 10135-642-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 29, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jul 29, 1999TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jul 29, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Citi
Cerilliant
Medtronic
Farmers Insurance
Dow
Chinese Patent Office
Daiichi Sankyo
Julphar

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