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Colorcon
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075303

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NDA 075303 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 075303
Tradename:LABETALOL HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075303
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075303
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075303 ANDA West-Ward Pharmaceuticals Corp 0143-9622 N 0143-9622-01
LABETALOL HYDROCHLORIDE labetalol hydrochloride INJECTABLE;INJECTION 075303 ANDA West-Ward Pharmaceuticals Corp 0143-9623 N 0143-9623-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:May 28, 1999TE:APRLD:No

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