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Serving 500+ biopharmaceutical companies globally:

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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

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
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
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
Fish and Richardson
Chinese Patent Office
Federal Trade Commission
US Department of Justice
Farmers Insurance
Harvard Business School

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