Source facts
FDA issued an approval letter for QUIOFIC on 2026-01-27. The source metadata identifies NDA 216395 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
QUIOFIC — FDA Approval Letter (NDA 216395)
Issued to SOLUBIOMIX. Application is approved as submitted.
Issued
January 27, 2026Application
NDA 505b1 • 216395
Product
QUIOFIC
Company
SOLUBIOMIX
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for QUIOFIC?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 216395.
- 3Submission: original application.
- 4Sponsor: SOLUBIOMIX.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the QUIOFIC approval letter
Is QUIOFIC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 216395 for QUIOFIC, sponsored by SOLUBIOMIX, on January 27, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 216395?
NDA 216395 is the application under which FDA issued this approval letter for QUIOFIC to SOLUBIOMIX. The letter is dated January 27, 2026.
What happens after an FDA approval letter?
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.