Source facts
FDA issued an approval letter for ZIRGAN on 2026-01-21. The source metadata identifies NDA 022211 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
ZIRGAN — FDA Approval Letter (NDA 022211)
Issued to BAUSCH AND LOMB. Application is approved as submitted.
Issued
January 21, 2026Application
NDA 505b1 • 022211
Product
ZIRGAN
Company
BAUSCH AND LOMB
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for ZIRGAN?
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 022211.
- 3Submission: supplement.
- 4Sponsor: BAUSCH AND LOMB.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the ZIRGAN approval letter
Is ZIRGAN FDA approved?
This letter documents an FDA approval action: FDA approved NDA 022211 for ZIRGAN, sponsored by BAUSCH AND LOMB, on January 21, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 022211?
NDA 022211 is the application under which FDA issued this approval letter for ZIRGAN to BAUSCH AND LOMB. The letter is dated January 21, 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.