Last Updated: November 13, 2026

Details for New Drug Application (NDA): 078694

« Back to Dashboard

NDA 078694 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 078694

Tradename:	BETAXOLOL HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	betaxolol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 078694

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Nov 16, 2009	TE:	AT	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.