Last Updated: November 8, 2026

Details for New Drug Application (NDA): 078962

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NDA 078962 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Chartwell Rx, Eurofarma, Pharmobedient, Epic Pharma, and Kvk Tech, and is included in six NDAs. It is available from three suppliers. Additional details are available on the BETAXOLOL HYDROCHLORIDE profile page.

The generic ingredient in BETAXOLOL HYDROCHLORIDE is betaxolol hydrochloride. There is one drug master file entry for this compound. Five 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

Pharmacology for NDA: 078962

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 078962

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 27, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 27, 2008	TE:	AB	RLD:	No

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