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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 23, 2018

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 seven 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. Nine suppliers are listed for this compound. Additional details are available on the betaxolol hydrochloride profile page.
Summary for 078962
Applicant:Kvk Tech
Ingredient:betaxolol hydrochloride
Therapeutic Class:Cardiovascular Agents
Ophthalmic Agents
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 N 10702-013-01
BETAXOLOL HYDROCHLORIDE betaxolol hydrochloride TABLET;ORAL 078962 ANDA KVK-TECH, INC. 10702-014 N 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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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Fish and Richardson
US Army
Express Scripts
US Department of Justice

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