Source facts
FDA issued an approval letter for PEPCID AC on 2026-02-13. The source metadata identifies NDA 020325 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
PEPCID AC — FDA Approval Letter (NDA 020325)
Issued to KENVUE BRANDS. Application is approved as submitted.
Issued
February 13, 2026Application
NDA 505b1 • 020325
Product
PEPCID AC
Company
KENVUE BRANDS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for PEPCID AC?
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 020325.
- 3Submission: supplement.
- 4Sponsor: KENVUE BRANDS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the PEPCID AC approval letter
Is PEPCID AC FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020325 for PEPCID AC, sponsored by KENVUE BRANDS, on February 13, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020325?
NDA 020325 is the application under which FDA issued this approval letter for PEPCID AC to KENVUE BRANDS. The letter is dated February 13, 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.