Issued to CARLSBAD. Application is approved as submitted.
Issued
June 16, 2026Application
ANDA 505j • 076126
Product
CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE / SKYRIZI
Company
CARLSBAD
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 CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, SKYRIZI on 2026-06-16. The source metadata identifies ANDA 076126, BLA 761105 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 ANDA 076126 for CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE / SKYRIZI, sponsored by CARLSBAD, on June 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 076126 is the application under which FDA issued this approval letter for CIPROFLOXACIN / CIPROFLOXACIN HYDROCHLORIDE / SKYRIZI to CARLSBAD. The letter is dated June 16, 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.