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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 078694

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NDA 078694 describes BETAXOLOL HYDROCHLORIDE, which is a drug marketed by Acella, Apotex Inc, Medimetriks Pharms, Sciegen Pharms Inc, 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 are eleven drug master file entries 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:	Acella
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

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