← FDA DRUG APPROVALS

FDA NDA · NDA203324

PHOTREXA CROSS-LINKING KIT

riboflavin 5-phosphate ophthalmic

Sponsor: GLAUKOS

APPLICATION
NDA203324
TYPE
NDA
ORIGINAL APPROVAL
2016-04-15
LATEST ACTION
2025-02-07
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

PHOTREXA VISCOUS IN DEXTRAN 20% · ReferencePrescription
RIBOFLAVIN 5'-PHOSPHATE 0.146% · SOLUTION/DROPS · OPHTHALMIC
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA · ReferencePrescription
RIBOFLAVIN 5'-PHOSPHATE SODIUM EQ 0.146% BASE/ML · SOLUTION/DROPS · OPHTHALMIC

Approval history

2025-02-07Labeling · Supplement 10 · standard — Letter ↗AP
2019-01-25Labeling · Supplement 6 · standard — Label ↗AP
2018-10-29Manufacturing (CMC) · Supplement 7 · standardAP
2016-07-15Efficacy · Original · priority — Label ↗AP
2016-04-15Type 3 - New Dosage Form · Original · priority — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →