Source facts
FDA issued an approval letter for CIPEPOFOL on 2026-06-02. The source metadata identifies NDA 220482 as an original application. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
CIPEPOFOL — FDA Approval Letter (NDA 220482)
Issued to HAISCO PHARMACEUTICAL GROUP CO LTD. Application is approved as submitted.
Issued
June 2, 2026Application
NDA 505b1 • 220482
Product
CIPEPOFOL
Company
HAISCO PHARMACEUTICAL GROUP CO LTD
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for CIPEPOFOL?
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 220482.
- 3Submission: original application.
- 4Sponsor: HAISCO PHARMACEUTICAL GROUP CO LTD.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the CIPEPOFOL approval letter
Is CIPEPOFOL FDA approved?
This letter documents an FDA approval action: FDA approved NDA 220482 for CIPEPOFOL, sponsored by HAISCO PHARMACEUTICAL GROUP CO LTD, on June 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 220482?
NDA 220482 is the application under which FDA issued this approval letter for CIPEPOFOL to HAISCO PHARMACEUTICAL GROUP CO LTD. The letter is dated June 2, 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.