Details for New Drug Application (NDA): 018086

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NDA 018086 describes TIMOPTIC, which is a drug marketed by Bausch And Lomb Inc and is included in three NDAs. It is available from three suppliers. Additional details are available on the TIMOPTIC profile page.

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

Summary for 018086

Tradename:	TIMOPTIC
Applicant:	Bausch And Lomb Inc
Ingredient:	timolol maleate
Patents:	0

Pharmacology for NDA: 018086

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 018086

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086	NDA	Bausch & Lomb Incorporated	24208-812	24208-812-05	1 BOTTLE, DISPENSING in 1 CARTON (24208-812-05) / 5 mL in 1 BOTTLE, DISPENSING
TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086	NDA	Bausch & Lomb Incorporated	24208-813	24208-813-05	1 BOTTLE, DISPENSING in 1 CARTON (24208-813-05) / 5 mL in 1 BOTTLE, DISPENSING

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT1	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT1	RLD:	Yes

Expired US Patents for NDA 018086

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-002	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	018086-001	Approved Prior to Jan 1, 1982	⤷ Subscribe	⤷ Subscribe
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