Source facts
FDA issued an approval letter for MEPRON on 2026-03-23. The source metadata identifies NDA 020500 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
MEPRON — FDA Approval Letter (NDA 020500)
Issued to GLAXOSMITHKLINE LLC. Application is approved as submitted.
Issued
March 23, 2026Application
NDA 505b1 • 020500
Product
MEPRON
Company
GLAXOSMITHKLINE LLC
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for MEPRON?
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 020500.
- 3Submission: supplement.
- 4Sponsor: GLAXOSMITHKLINE LLC.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the MEPRON approval letter
Is MEPRON FDA approved?
This letter documents an FDA approval action: FDA approved NDA 020500 for MEPRON, sponsored by GLAXOSMITHKLINE LLC, on March 23, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 020500?
NDA 020500 is the application under which FDA issued this approval letter for MEPRON to GLAXOSMITHKLINE LLC. The letter is dated March 23, 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.