Last Updated: November 13, 2026

Details for New Drug Application (NDA): 019387

NDA 019387 describes PROFENAL, which is a drug marketed by Alcon and is included in one NDA. Additional details are available on the PROFENAL profile page.

The generic ingredient in PROFENAL is suprofen. There is one drug master file entry for this compound. Additional details are available on the suprofen profile page.

Summary for 019387

Tradename:	PROFENAL
Applicant:	Alcon
Ingredient:	suprofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 019387

Anti-Inflammatory Agents, Non-Steroidal
Cyclooxygenase Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	1%
Approval Date:	Dec 23, 1988	TE:		RLD:	No

Expired US Patents for NDA 019387

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alcon	PROFENAL	suprofen	SOLUTION/DROPS;OPHTHALMIC	019387-001	Dec 23, 1988	4,035,376	⤷ Start Trial
Alcon	PROFENAL	suprofen	SOLUTION/DROPS;OPHTHALMIC	019387-001	Dec 23, 1988	4,559,343	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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