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Generated: January 23, 2019

DrugPatentWatch Database Preview

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. Eighteen 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:➤ Try a Free TrialPatent Expiration:Nov 2, 2018Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Nov 16, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021516

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 ➤ Try a Free Trial ➤ Try a Free Trial
Bausch And Lomb ISTALOL timolol maleate SOLUTION/DROPS;OPHTHALMIC 021516-001 Jun 4, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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