Source facts
FDA issued an approval letter for RETIN-A MICRO, RETIN-A-MICRO on 2026-04-07. The source metadata identifies NDA 020475 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
RETIN-A MICRO / RETIN-A-MICRO — FDA Approval Letter (NDA 020475)
Issued to BAUSCH. Application is approved as submitted.
Issued
April 7, 2026Application
NDA 505b1 • 020475
Product
RETIN-A MICRO / RETIN-A-MICRO
Company
BAUSCH
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for RETIN-A MICRO / RETIN-A-MICRO?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 020475.
- 3Submission: supplement.
- 4Sponsor: BAUSCH.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the RETIN-A MICRO / RETIN-A-MICRO approval letter
Is RETIN-A MICRO / RETIN-A-MICRO FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020475 for RETIN-A MICRO / RETIN-A-MICRO, sponsored by BAUSCH, on April 7, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020475?
NDA 020475 is the application under which FDA issued this approval letter for RETIN-A MICRO / RETIN-A-MICRO to BAUSCH. The letter is dated April 7, 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.