Details for New Drug Application (NDA): 019463

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NDA 019463 describes TIMOPTIC IN OCUDOSE, which is a drug marketed by Valeant Pharms Intl and is included in one NDA. It is available from one supplier. Additional details are available on the TIMOPTIC IN OCUDOSE profile page.

The generic ingredient in TIMOPTIC IN OCUDOSE is timolol maleate. There are fifteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 019463

Tradename:	TIMOPTIC IN OCUDOSE
Applicant:	Valeant Pharms Intl
Ingredient:	timolol maleate
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 019463

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 019463

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463	NDA	Bausch Health US LLC	0187-1496	0187-1496-05	4 POUCH in 1 CARTON (0187-1496-05) > 15 CONTAINER in 1 POUCH > .3 mL in 1 CONTAINER
TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463	NDA	Bausch Health US LLC	0187-1496	0187-1496-99	10 POUCH in 1 CARTON (0187-1496-99) > .3 mL in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Nov 5, 1986	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Nov 5, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 019463

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharms Intl	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-001	Nov 5, 1986	Start Trial	Start Trial
Valeant Pharms Intl	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	Start Trial	Start Trial
Valeant Pharms Intl	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-002	Nov 5, 1986	Start Trial	Start Trial
Valeant Pharms Intl	TIMOPTIC IN OCUDOSE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	019463-001	Nov 5, 1986	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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