Source facts
FDA issued an approval letter for FIORICET W/ CODEINE on 2026-06-23. The source metadata identifies NDA 020232 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
FIORICET W/ CODEINE — FDA Approval Letter (NDA 020232)
Issued to ACTAVIS LABS UT INC. Application is approved as submitted.
Issued
June 23, 2026Application
NDA 505b1 • 020232
Product
FIORICET W/ CODEINE
Company
ACTAVIS LABS UT INC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for FIORICET W/ CODEINE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 020232.
- 3Submission: supplement.
- 4Sponsor: ACTAVIS LABS UT INC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the FIORICET W/ CODEINE approval letter
Is FIORICET W/ CODEINE FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020232 for FIORICET W/ CODEINE, sponsored by ACTAVIS LABS UT INC, on June 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020232?
NDA 020232 is the application under which FDA issued this approval letter for FIORICET W/ CODEINE to ACTAVIS LABS UT INC. The letter is dated June 23, 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.