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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 207743

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NDA 207743 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 207743
Tradename:LABETALOL HYDROCHLORIDE
Applicant:Zydus Pharms
Ingredient:labetalol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207743
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 207743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207743 ANDA American Health Packaging 60687-439 60687-439-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-439-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-439-11)
LABETALOL HYDROCHLORIDE labetalol hydrochloride TABLET;ORAL 207743 ANDA American Health Packaging 60687-450 60687-450-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-450-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-450-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Sep 19, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Sep 19, 2017TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength300MG
Approval Date:Sep 19, 2017TE:ABRLD:No

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