← FDA DRUG APPROVALS

FDA NDA · NDA021565

ELESTAT

Sponsor: ALLERGAN

APPLICATION
NDA021565
TYPE
NDA
ORIGINAL APPROVAL
2003-10-16
LATEST ACTION
2016-02-25
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ELESTAT · ReferenceDiscontinued
EPINASTINE HYDROCHLORIDE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2016-02-25Manufacturing (CMC) · Supplement 8 · standardAP
2013-06-17Manufacturing (CMC) · Supplement 7 · standardAP
2011-12-20Labeling · Supplement 6 · unknown — Label ↗AP
2005-08-15Manufacturing (CMC) · Supplement 5 · standard — Label ↗AP
2003-10-16Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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