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Generated: August 21, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 079134

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NDA 079134 describes LABETALOL HYDROCHLORIDE, which is a drug marketed by West-ward Pharms Int, Par Form, Sandoz, Allied Pharma Inc, Apothecon, Akorn Inc, Watson Labs, Sagent Agila Llc, 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 fourteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for NDA: 079134

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Feb 3, 2010TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Citi
Accenture
UBS
Moodys
Harvard Business School
Julphar
Daiichi Sankyo
Chubb
Merck
Baxter

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