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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078962

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NDA 078962 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Akorn, Apotex Inc, Medimetriks Pharms, Wockhardt, Epic Pharma, and Kvk Tech, and is included in six NDAs. It is available from five suppliers. Additional details are available on the BETAXOLOL HYDROCHLORIDE profile page.

The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 078962
Tradename:BETAXOLOL HYDROCHLORIDE
Applicant:Kvk Tech
Ingredient:betaxolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078962
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 078962
Suppliers and Packaging for NDA: 078962
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962 ANDA KVK-TECH, INC. 10702-013 10702-013-01 100 TABLET, COATED in 1 BOTTLE (10702-013-01)
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962 ANDA KVK-TECH, INC. 10702-014 10702-014-01 100 TABLET, COATED in 1 BOTTLE (10702-014-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 27, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Jun 27, 2008TE:ABRLD:No

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