Issued to SCHERING. Application is approved as submitted.
Issued
January 27, 2026Application
NDA 505b1 • 022003
Product
NOXAFIL / NOXAFIL POWDERMIX KIT
Company
SCHERING
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued an approval letter for NOXAFIL, NOXAFIL POWDERMIX KIT on 2026-01-27. The source metadata identifies NDA 022003, NDA 205053, NDA 205596, NDA 214770 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 022003 for NOXAFIL / NOXAFIL POWDERMIX KIT, sponsored by SCHERING, on January 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 022003 is the application under which FDA issued this approval letter for NOXAFIL / NOXAFIL POWDERMIX KIT to SCHERING. The letter is dated January 27, 2026.
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.