Last Updated: November 13, 2026

Details for New Drug Application (NDA): 075446

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NDA 075446 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 075446

Tradename:	BETAXOLOL HYDROCHLORIDE
Applicant:	Apotex Inc
Ingredient:	betaxolol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 075446

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Sep 28, 2000	TE:		RLD:	No

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