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Last Updated: July 10, 2020

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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. Seven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019845
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 019845
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 Alcon Laboratories, Inc. 0065-0246 0065-0246-10 1 BOTTLE, PLASTIC in 1 CARTON (0065-0246-10) > 10 mL in 1 BOTTLE, PLASTIC
BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845 NDA Alcon Laboratories, Inc. 0065-0246 0065-0246-15 1 BOTTLE, PLASTIC in 1 CARTON (0065-0246-15) > 15 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Dec 29, 1989TE:RLD:Yes

Expired US Patents for NDA 019845

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   Start Trial   Start Trial
Novartis BETOPTIC S betaxolol hydrochloride SUSPENSION/DROPS;OPHTHALMIC 019845-001 Dec 29, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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