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Generated: November 12, 2018

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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 two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Seventeen 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021516
Mechanism of ActionAdrenergic 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:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Jun 4, 2004TE:AT2RLD:Yes
Patent:➤ Sign UpPatent Expiration:Nov 2, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Nov 16, 2018Product Flag?YSubstance Flag?Delist Request?

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