Source facts
FDA issued an approval letter for TEGRETOL, TEGRETOL-XR on 2026-07-16. The source metadata identifies NDA 016608, NDA 018927, NDA 020234 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
TEGRETOL / TEGRETOL-XR — FDA Approval Letter (NDA 016608)
Issued to NOVARTIS. Application is approved as submitted.
Issued
July 16, 2026Application
NDA 505b1 • 016608
Product
TEGRETOL / TEGRETOL-XR
Company
NOVARTIS
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for TEGRETOL / TEGRETOL-XR?
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.
- 2Applications: NDA 016608, NDA 018927, NDA 020234.
- 3Submission: supplement.
- 4Sponsor: NOVARTIS.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the TEGRETOL / TEGRETOL-XR approval letter
Is TEGRETOL / TEGRETOL-XR FDA approved?
This letter documents an FDA approval action: FDA approved NDA 016608 for TEGRETOL / TEGRETOL-XR, sponsored by NOVARTIS, on July 16, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 016608?
NDA 016608 is the application under which FDA issued this approval letter for TEGRETOL / TEGRETOL-XR to NOVARTIS. The letter is dated July 16, 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.