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FDA NDA · NDA021066

ZADITOR

Sponsor: ALCON PHARMA

APPLICATION
NDA021066
TYPE
NDA
ORIGINAL APPROVAL
1999-07-02
LATEST ACTION
2012-05-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

ZADITOR · ReferenceDiscontinued
KETOTIFEN FUMARATE EQ 0.025% BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2012-05-03Labeling · Supplement 18 · standard — Label ↗AP
2008-07-09Labeling · Supplement 13 · standard — Letter ↗AP
2006-10-19Efficacy · Supplement 11 · standard — Letter ↗AP
2006-09-21Manufacturing (CMC) · Supplement 12AP
2002-10-04Manufacturing (CMC) · Supplement 5 · priorityAP
2001-07-20Labeling · Supplement 4 · standard — Label ↗AP
2000-12-26Manufacturing (CMC) · Supplement 3 · priorityAP
2000-07-24Manufacturing (CMC) · Supplement 2 · priorityAP
2000-03-08Labeling · Supplement 1 · standard — Review ↗AP
1999-07-02Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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