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FDA Approval

XENOVIEW

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Polarean, Inc.
DUNS: 078629330
Effective Date
December 30, 2022
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Xenon Xe-129(75 mL in 1 L)

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

XENOVIEW

Product Details

NDC Product Code
80534-1000
Application Number
NDA214375
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 4, 2023
Code: 726Q6M95ZAClass: ACTIBQuantity: 75 mL in 1 L

XENOVIEW

Product Details

NDC Product Code
80534-6350
Application Number
NDA214375
Marketing Category
NDA (C73594)
Route of Administration
RESPIRATORY (INHALATION)
Effective Date
January 4, 2023
Code: 9C7571UDT5Class: ACTIBQuantity: 63.5 L in 1 1
NitrogenActive
Code: N762921K75Class: ACTIBQuantity: 635 L in 1 1
HeliumActive
Code: 206GF3GB41Class: ACTIBQuantity: 5651.5 L in 1 1
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