Details for New Drug Application (NDA): 019219

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NDA 019219 describes BETAGAN, which is a drug marketed by Allergan and is included in two NDAs. It is available from one supplier. Additional details are available on the BETAGAN profile page.

The generic ingredient in BETAGAN is levobunolol hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the levobunolol hydrochloride profile page.

Summary for 019219

Tradename:	BETAGAN
Applicant:	Allergan
Ingredient:	levobunolol hydrochloride
Patents:	0

Pharmacology for NDA: 019219

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 019219

Adrenergic beta-Antagonists
Sympatholytics

Suppliers and Packaging for NDA: 019219

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-060	60758-060-05	1 BOTTLE, DROPPER in 1 CARTON (60758-060-05) > 5 mL in 1 BOTTLE, DROPPER
BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219	NDA AUTHORIZED GENERIC	Pacific Pharma, Inc.	60758-060	60758-060-10	1 BOTTLE, DROPPER in 1 CARTON (60758-060-10) > 10 mL in 1 BOTTLE, DROPPER

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Dec 19, 1985	TE:	AT	RLD:	Yes

Expired US Patents for NDA 019219

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	BETAGAN	levobunolol hydrochloride	SOLUTION/DROPS;OPHTHALMIC	019219-002	Dec 19, 1985	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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