Source facts
FDA issued an approval letter for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE on 2026-01-13. The source metadata identifies ANDA 218273 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE — FDA Approval Letter (ANDA 218273)
Issued to COSETTE PHARMS NC. Application is approved as submitted.
Issued
January 13, 2026Application
ANDA 505j • 218273
Product
CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
Company
COSETTE PHARMS NC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE?
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Key details in this letter
- 1FDA action: approval.
- 2Application: ANDA 218273.
- 3Submission: original application.
- 4Sponsor: COSETTE PHARMS NC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE approval letter
Is CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE FDA approved?
This letter documents an FDA approval action: FDA approved ANDA 218273 for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE, sponsored by COSETTE PHARMS NC, on January 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is ANDA 218273?
ANDA 218273 is the application under which FDA issued this approval letter for CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE to COSETTE PHARMS NC. The letter is dated January 13, 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.