Details for New Drug Application (NDA): 020330

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NDA 020330 describes TIMOPTIC-XE, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TIMOPTIC-XE profile page.

The generic ingredient in TIMOPTIC-XE 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 020330

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

Pharmacology for NDA: 020330

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 020330

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330	NDA	Bausch & Lomb Incorporated	24208-814	24208-814-25	1 BOTTLE, DISPENSING in 1 CARTON (24208-814-25) / 5 mL in 1 BOTTLE, DISPENSING
TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330	NDA	Bausch & Lomb Incorporated	24208-816	24208-816-05	1 BOTTLE, DISPENSING in 1 CARTON (24208-816-05) / 5 mL in 1 BOTTLE, DISPENSING

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Nov 4, 1993	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Nov 4, 1993	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020330

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	4,195,085	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	4,861,760	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-002	Nov 4, 1993	4,195,085	⤷ Subscribe
Bausch And Lomb Inc	TIMOPTIC-XE	timolol maleate	SOLUTION, GEL FORMING/DROPS;OPHTHALMIC	020330-001	Nov 4, 1993	4,861,760	⤷ Subscribe
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