Details for New Drug Application (NDA): 019270

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NDA 019270 describes BETOPTIC, which is a drug marketed by Sandoz, Alcon, and Novartis, and is included in three NDAs. It is available from one supplier. Additional details are available on the BETOPTIC profile page.

The generic ingredient in BETOPTIC is betaxolol hydrochloride; pilocarpine hydrochloride. There are eleven drug master file entries for this compound. Additional details are available on the betaxolol hydrochloride; pilocarpine hydrochloride profile page.

Summary for 019270

Tradename:	BETOPTIC
Applicant:	Sandoz
Ingredient:	betaxolol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 019270

Adrenergic beta-1 Receptor Antagonists
Antihypertensive Agents
Sympatholytics

Suppliers and Packaging for NDA: 019270

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245	61314-245-01	1 BOTTLE, PLASTIC in 1 CARTON (61314-245-01) / 5 mL in 1 BOTTLE, PLASTIC
BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-245	61314-245-02	1 BOTTLE, PLASTIC in 1 CARTON (61314-245-02) / 15 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Aug 30, 1985	TE:	AT	RLD:	Yes

Expired US Patents for NDA 019270

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	⤷ Sign Up	⤷ Sign Up
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	⤷ Sign Up	⤷ Sign Up
Sandoz	BETOPTIC	betaxolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019270-001	Aug 30, 1985	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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