Issued to GALDERMA LABS LP. Application is approved as submitted.
Posted by FDA
May 22, 2026Application
NDA 505b1 • 220736
Product
DIFFERIN EPIDUO / DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE)
Company
GALDERMA LABS LP
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for DIFFERIN EPIDUO, DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) on 2026-05-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 220736 as an original application. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 220736 for DIFFERIN EPIDUO / DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE), sponsored by GALDERMA LABS LP,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 220736 is the application under which FDA issued this approval letter for DIFFERIN EPIDUO / DIFFERIN EPIDUO ACNE GEL (ADAPALENE AND BENZOYL PEROXIDE) to GALDERMA LABS LP. FDA posted the letter on May 22, 2026; the posting date is not the decision date.
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.