APPLICATION
ANDA203431
TYPE
ANDA
ORIGINAL APPROVAL
2015-07-10
LATEST ACTION
2020-09-03
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TRAVOPROSTPrescription
TRAVOPROST 0.004% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2020-09-03Labeling · Supplement 10 · standardAP
2020-01-27Labeling · Supplement 1 · standardAP
2020-01-27Manufacturing (CMC) · Supplement 5 · unknownAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.