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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 090919

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NDA 090919 describes EPINASTINE HYDROCHLORIDE, which is a drug marketed by Apotex, Breckenridge, Chartwell Rx, Epic Pharma Llc, 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 090919

Tradename:	EPINASTINE HYDROCHLORIDE
Applicant:	Apotex
Ingredient:	epinastine hydrochloride
Patents:	0

Profile for product number 001

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

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