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Generated: May 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203491

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NDA 203491 describes ILEVRO, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ILEVRO profile page.

The generic ingredient in ILEVRO is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.
Summary for 203491
Tradename:ILEVRO
Applicant:Novartis Pharms Corp
Ingredient:nepafenac
Patents:3
Pharmacology for NDA: 203491
Suppliers and Packaging for NDA: 203491
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491 NDA Alcon Laboratories, Inc. 0065-1750 0065-1750-07 1 BOTTLE, DROPPER in 1 CARTON (0065-1750-07) > 1.7 mL in 1 BOTTLE, DROPPER
ILEVRO nepafenac SUSPENSION/DROPS;OPHTHALMIC 203491 NDA Alcon Laboratories, Inc. 0065-1750 0065-1750-08 1 BOTTLE, DROPPER in 1 CARTON (0065-1750-08) > .8 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.3%
Approval Date:Oct 16, 2012TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jun 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 31, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Dec 1, 2030Product Flag?YSubstance Flag?Delist Request?

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