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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 200908

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NDA 200908 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, Athem, Cadila Pharms Ltd, Heritage Pharma, Innogenix, Par Form, Sandoz, Teva, Twi Pharms, Watson Labs, and Zydus Pharms, and is included in twenty-one NDAs. It is available from twenty-six 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. Twenty-seven suppliers are listed for this compound. Additional details are available on the labetalol hydrochloride profile page.
Summary for 200908
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Par Form
Ingredient:labetalol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200908
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 200908
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 200908 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8130 0615-8130-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8130-39)
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 200908 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8131 0615-8131-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8131-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Jul 10, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Jul 10, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Jul 10, 2012TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

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Dow
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