Source facts
FDA issued an approval letter for NIZORAL ANTI-DANDRUFF on 2026-05-04. The source metadata identifies NDA 020310 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
NIZORAL ANTI-DANDRUFF — FDA Approval Letter (NDA 020310)
Issued to KRAMER. Application is approved as submitted.
Issued
May 4, 2026Application
NDA 505b1 • 020310
Product
NIZORAL ANTI-DANDRUFF
Company
KRAMER
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for NIZORAL ANTI-DANDRUFF?
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Key details in this letter
- 1FDA action: approval.
- 2Application: NDA 020310.
- 3Submission: supplement.
- 4Sponsor: KRAMER.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the NIZORAL ANTI-DANDRUFF approval letter
Is NIZORAL ANTI-DANDRUFF FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020310 for NIZORAL ANTI-DANDRUFF, sponsored by KRAMER, on May 4, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020310?
NDA 020310 is the application under which FDA issued this approval letter for NIZORAL ANTI-DANDRUFF to KRAMER. The letter is dated May 4, 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.