Last Updated: September 24, 2026

Details for New Drug Application (NDA): 091626

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NDA 091626 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 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 091626

Tradename:	EPINASTINE HYDROCHLORIDE
Applicant:	Sun Pharm Inds
Ingredient:	epinastine hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.05%
Approval Date:	Oct 31, 2011	TE:		RLD:	No

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