Details for New Drug Application (NDA): 203491

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NDA 203491 describes ILEVRO, which is a drug marketed by Harrow Eye and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

Summary for 203491

Tradename:	ILEVRO
Applicant:	Harrow Eye
Ingredient:	nepafenac
Patents:	3

Pharmacology for NDA: 203491

Mechanism of Action	Cyclooxygenase Inhibitors

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	Novartis Pharmaceuticals Corporation	0078-0743	0078-0743-03	1 BOTTLE in 1 CARTON (0078-0743-03) / 3 mL in 1 BOTTLE
ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491	NDA	Novartis Pharmaceuticals Corporation	0078-0743	0078-0743-96	1 BOTTLE in 1 CARTON (0078-0743-96) / .8 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION/DROPS;OPHTHALMIC			Strength	0.3%
Approval Date:	Oct 16, 2012	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 8, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 31, 2032	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Dec 1, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 203491

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	⤷ Sign Up	⤷ Sign Up
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	⤷ Sign Up	⤷ Sign Up
Harrow Eye	ILEVRO	nepafenac	SUSPENSION/DROPS;OPHTHALMIC	203491-001	Oct 16, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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