Cytalux
These highlights do not include all the information needed to use CYTALUX safely and effectively. See full prescribing information for CYTALUX. CYTALUX™ (pafolacianine) injection, for intravenous use Initial U.S. Approval: 2021
Approved
Approval ID
d21952b9-7c4e-3a56-e053-2a95a90a0ab0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
On Target Laboratories, Inc.
DUNS: 968729181
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pafolacianine injection
PRODUCT DETAILS
NDC Product Code81052-138
Application NumberNDA214907
Marketing CategoryC73594
Route of AdministrationINTRAVENOUS
Effective DateJuly 12, 2023
Generic NamePafolacianine injection
INGREDIENTS (7)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive
Code: 70WT22SF4B
Classification: IACT
PAFOLACIANINE SODIUMActive
Quantity: 3.2 mg in 1.6 mL
Code: 4HUF3V875C
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT