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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 008883

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NDA 008883 describes OPHTHAINE, which is a drug marketed by Apothecon and is included in one NDA. Additional details are available on the OPHTHAINE profile page.

The generic ingredient in OPHTHAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.

Summary for 008883

Tradename:	OPHTHAINE
Applicant:	Apothecon
Ingredient:	proparacaine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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