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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 019845

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NDA 019845 describes BETOPTIC S, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the BETOPTIC S profile page.

The generic ingredient in BETOPTIC S 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 019845

Tradename:	BETOPTIC S
Applicant:	Novartis
Ingredient:	betaxolol hydrochloride
Patents:	0

Pharmacology for NDA: 019845

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 019845

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 019845

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729	0078-0729-10	1 BOTTLE in 1 CARTON (0078-0729-10) / 10 mL in 1 BOTTLE
BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845	NDA	Novartis Pharmaceuticals Corporation	0078-0729	0078-0729-15	1 BOTTLE in 1 CARTON (0078-0729-15) / 15 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Dec 29, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 019845

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989	4,911,920*PED	⤷ Get Started Free
Novartis	BETOPTIC S	betaxolol hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	019845-001	Dec 29, 1989	4,342,783	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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