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Last Updated: July 16, 2024

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 are six drug master file entries for this compound. Two suppliers are 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:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Oct 16, 2003TE:RLD:Yes

Expired US Patents for NDA 021565

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

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