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FDA NDA · NDA022555

CYSVIEW

hexaminolevulinate hydrochloride

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APPLICATION
NDA022555
TYPE
NDA
ORIGINAL APPROVAL
2010-05-28
LATEST ACTION
2026-06-18
ROUTE
INTRAVESICAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription

Products

CYSVIEW KIT · ReferencePrescription
HEXAMINOLEVULINATE HYDROCHLORIDE 100MG/VIAL · FOR SOLUTION · INTRAVESICAL

Approval history

2026-06-18Labeling · Supplement 6 · standard — Letter ↗AP
2018-02-15Efficacy · Supplement 5 · priority — Label ↗AP
2016-07-29Manufacturing (CMC) · Supplement 4 · priority — Label ↗AP
2012-11-28Manufacturing (CMC) · Supplement 3 · priorityAP
2010-05-28Type 3 - New Dosage Form · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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