← FDA DRUG APPROVALS

FDA NDA · NDA204822

IZBA

Sponsor: NOVARTIS

APPLICATION
NDA204822
TYPE
NDA
ORIGINAL APPROVAL
2014-05-15
LATEST ACTION
2021-06-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

IZBA · ReferenceDiscontinued
TRAVOPROST 0.003% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2021-06-09Labeling · Supplement 2 · standardLetterAP
2014-05-15Type 5 - New Formulation or New Manufacturer · Original · standardLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →