Source facts
FDA issued an approval letter for IC-GREEN on 2026-07-20. The source metadata identifies NDA 011525 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
IC-GREEN — FDA Approval Letter (NDA 011525)
Issued to RENEW PHARMS. Application is approved as submitted.
Issued
July 20, 2026Application
NDA 505b1 • 011525
Product
IC-GREEN
Company
RENEW PHARMS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for IC-GREEN?
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 011525.
- 3Submission: supplement.
- 4Sponsor: RENEW PHARMS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the IC-GREEN approval letter
Is IC-GREEN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 011525 for IC-GREEN, sponsored by RENEW PHARMS, on July 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 011525?
NDA 011525 is the application under which FDA issued this approval letter for IC-GREEN to RENEW PHARMS. The letter is dated July 20, 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.