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FDA NDA · NDA214907

CYTALUX

pafolacianine injection

Sponsor: ON TARGET LABS

APPLICATION
NDA214907
TYPE
NDA
ORIGINAL APPROVAL
2021-11-29
LATEST ACTION
2022-12-16
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

CYTALUX · ReferencePrescription
PAFOLACIANINE SODIUM EQ 3.2MG BASE/1.6ML (EQ 2MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2022-12-16Efficacy · Supplement 2 · priority — Label ↗AP
2021-11-29Type 1 - New Molecular Entity · Original · priority — Letter ↗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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