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FDA NDA · NDA021257

TRAVATAN

Sponsor: ALCON PHARMS LTD

APPLICATION
NDA021257
TYPE
NDA
ORIGINAL APPROVAL
2001-03-16
LATEST ACTION
2011-09-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

TRAVATAN · ReferenceDiscontinued
TRAVOPROST 0.004% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2011-09-07Labeling · Supplement 25 · unknown — Label ↗AP
2010-08-31Efficacy · Supplement 18 · standard — Letter ↗AP
2006-01-23Labeling · Supplement 15 · standard — Letter ↗AP
2006-01-23Manufacturing (CMC) · Supplement 14 · priority — Label ↗AP
2004-02-20Labeling · Supplement 13 · standard — Letter ↗AP
2004-02-20Manufacturing (CMC) · Supplement 12 · priority — Letter ↗AP
2003-05-15Manufacturing (CMC) · Supplement 10 · priority — Label ↗AP
2003-02-13Labeling · Supplement 8 · standard — Letter ↗AP
2003-02-13Efficacy · Supplement 6 · standard — Label ↗AP
2003-02-13Labeling · Supplement 9 · standard — Label ↗AP
2002-12-04Manufacturing (CMC) · Supplement 7 · priorityAP
2002-12-04Manufacturing (CMC) · Supplement 5 · priorityAP
2002-08-28Manufacturing (CMC) · Supplement 3 · priorityAP
2002-03-25Manufacturing (CMC) · Supplement 1 · priorityAP
2002-02-15Manufacturing (CMC) · Supplement 2 · priorityAP
2001-03-16Type 1 - New Molecular Entity · Original · priority — Review ↗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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