← FDA DRUG APPROVALS

FDA NDA · NDA021994

TRAVATAN Z

travoprost

Sponsor: SANDOZ

APPLICATION
NDA021994
TYPE
NDA
ORIGINAL APPROVAL
2006-09-21
LATEST ACTION
2025-10-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

TRAVATAN Z · ReferencePrescription
TRAVOPROST 0.004% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-10-09Labeling · Supplement 20 · standard — Label ↗AP
2020-04-02Labeling · Supplement 13 · standard — Letter ↗AP
2017-09-22Labeling · Supplement 12 · standard — Letter ↗AP
2016-03-11Manufacturing (CMC) · Supplement 9 · standardAP
2011-09-07Labeling · Supplement 6 · unknown — Label ↗AP
2010-08-31Efficacy · Supplement 1 · unknown — Label ↗AP
2006-09-21Type 5 - New Formulation or New Manufacturer · Original · standard — 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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