You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 22, 2024

Details for New Drug Application (NDA): 090919

✉ Email this page to a colleague

« Back to Dashboard

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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.