Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021565

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NDA 021565 describes ELESTAT, which is a drug marketed by Allergan and is included in one NDA. Additional details are available on the ELESTAT profile page.

The generic ingredient in ELESTAT is epinastine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for 021565

Tradename:	ELESTAT
Applicant:	Allergan
Ingredient:	epinastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Oct 16, 2003	TE:		RLD:	Yes

Expired US Patents for NDA 021565

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ELESTAT	epinastine hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021565-001	Oct 16, 2003	7,429,602	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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