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Generated: April 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075113

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NDA 075113 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 075113
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Sandoz
Ingredient:labetalol hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075113
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075113
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075113 ANDA Eon Labs, Inc. 0185-0010 N 0185-0010-05
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 075113 ANDA Eon Labs, Inc. 0185-0010 N 0185-0010-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 4, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Aug 4, 1998TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Aug 4, 1998TE:ABRLD:No

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