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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203384

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NDA 203384 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Chartwell Rx, Epic Pharma Llc, Pharmobedient, Somerset Theraps Llc, and Sun Pharm Inds, and is included in six NDAs. It is available from one supplier. Additional details are available on the EPINASTINE HYDROCHLORIDE profile page.

The generic ingredient in EPINASTINE HYDROCHLORIDE is epinastine hydrochloride. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the epinastine hydrochloride profile page.

Summary for 203384

Tradename:	EPINASTINE HYDROCHLORIDE
Applicant:	Chartwell Rx
Ingredient:	epinastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Dec 7, 2016	TE:		RLD:	No

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