Elestat

NDA 21565, held by Allergan. Epinastine Hydrochloride.

As of Nov 14, 2026, NDA 21565 (Elestat), held by Allergan, was first approved by FDA on Oct 16, 2003, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 16, 2003
Review: Standard
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Oct 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Elestat0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · solution/drops;ophthalmic	Epinastine Hydrochloride	DiscontinuedReference drug

All 5 submissions, including labeling and manufacturing supplements


Feb 25, 2016	Supplement 8Manufacturing · Standard review	Approved	None posted
Jun 17, 2013	Supplement 7Manufacturing · Standard review	Approved	None posted
Dec 20, 2011	Supplement 6Labeling	Approved	Label Letter
Aug 15, 2005	Supplement 5Manufacturing · Standard review	Approved	Letter Label
Oct 16, 2003	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21565
Drugs@FDA: Overview at FDA
Company: Allergan

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters