POSLUMA
These highlights do not include all the information needed to use POSLUMA safely and effectively. See full prescribing information for POSLUMA. POSLUMA (flotufolastat F 18) injection, for intravenous use Initial U.S. Approval: 2023
Approved
Approval ID
907ac4a4-a088-4826-ab50-cfc31985c9d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Blue Earth Diagnostics
DUNS: 219742530
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
flotufolastat F-18
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69932-002
Application NumberNDA216023
Product Classification
M
Marketing Category
C73594
G
Generic Name
flotufolastat F-18
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (5)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
FLOTUFOLASTAT F-18Active
Quantity: 158 mCi in 1 mL
Code: 811W19E3OL
Classification: ACTIB