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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 021516

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NDA 021516 describes ISTALOL, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from three suppliers. Additional details are available on the ISTALOL profile page.

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

Summary for 021516

Tradename:	ISTALOL
Applicant:	Bausch And Lomb
Ingredient:	timolol maleate
Patents:	0

Pharmacology for NDA: 021516

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 021516

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516	NDA	Bausch & Lomb Incorporated	24208-004	24208-004-01	1 BOTTLE, DROPPER in 1 CARTON (24208-004-01) / 2.5 mL in 1 BOTTLE, DROPPER
ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516	NDA	Bausch & Lomb Incorporated	24208-004	24208-004-02	1 BOTTLE, DROPPER in 1 CARTON (24208-004-02) / 2.5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Jun 4, 2004	TE:	AT2	RLD:	Yes

Expired US Patents for NDA 021516

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	⤷ Get Started Free	⤷ Get Started Free
Bausch And Lomb	ISTALOL	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	021516-001	Jun 4, 2004	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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