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Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075239

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NDA 075239 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 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-three suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.

Summary for NDA: 075239

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

Pharmacology for NDA: 075239

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 075239

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE
labetalol hydrochloride
INJECTABLE;INJECTION 075239 ANDA Hospira, Inc. 0409-2339 0409-2339-34 10 CARTON in 1 PACKAGE (0409-2339-34) > 1 CARTRIDGE in 1 CARTON > 4 mL in 1 CARTRIDGE
LABETALOL HYDROCHLORIDE
labetalol hydrochloride
INJECTABLE;INJECTION 075239 ANDA Cardinal Health 55154-4747 55154-4747-5 5 SYRINGE in 1 BAG (55154-4747-5) > 4 mL in 1 SYRINGE

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Julphar
Merck
Fish and Richardson
Chinese Patent Office
Federal Trade Commission
Deloitte
US Department of Justice
Farmers Insurance
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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