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Nonrulemaking
FDA
Open for Comments
FDA-2025-P-7112
Requests that FDA determine whether Fluosol® (20% Intravascular Perfluorochemical Emulsion) approved under New Drug Application (NDA) 86-0909, held by Alpha Therapeutic Corporation, has been voluntarily withdrawn from sale for reasons of safety or effectiveness, pursuant to 21 CFR S 314.161
Documents
3
Comments
0
Description
Open
Key Dates
Comment Period OpensDec 16, 2025
Documents
| Type | Title | Status |
|---|---|---|
Other |
Keywords
CBER
Citizen Petition
Swaza, Inc.
Requests that FDA determine whether Fluosol®
(20% Intravascular Perfluorochemical Emulsion)
approved under New Drug Application
(NDA) 86-0909, held by
Alpha Therapeutic Corporation, has been
Data from Regulations.gov