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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 019404

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NDA 019404 describes OCUFEN, which is a drug marketed by Allergan and is included in one NDA. Additional details are available on the OCUFEN profile page.

The generic ingredient in OCUFEN is flurbiprofen sodium. There are twelve drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.

Summary for 019404

Tradename:	OCUFEN
Applicant:	Allergan
Ingredient:	flurbiprofen sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.03% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 31, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 019404

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986	3,793,457	⤷ Get Started Free
Allergan	OCUFEN	flurbiprofen sodium	SOLUTION/DROPS;OPHTHALMIC	019404-001	Dec 31, 1986	3,755,427	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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