Source facts
FDA issued an approval letter for DEPAKOTE, DEPAKOTE ER on 2026-04-02. The source metadata identifies NDA 018723, NDA 019680, NDA 021168 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
DEPAKOTE / DEPAKOTE ER — FDA Approval Letter (NDA 018723)
Issued to ABBVIE. Application is approved as submitted.
Issued
April 2, 2026Application
NDA 505b1 • 018723
Product
DEPAKOTE / DEPAKOTE ER
Company
ABBVIE
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for DEPAKOTE / DEPAKOTE ER?
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Key details in this letter
- 1FDA action: approval.
- 2Applications: NDA 018723, NDA 019680, NDA 021168.
- 3Submission: supplement.
- 4Sponsor: ABBVIE.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the DEPAKOTE / DEPAKOTE ER approval letter
Is DEPAKOTE / DEPAKOTE ER FDA approved?
This letter documents an FDA approval action: FDA approved NDA 018723 for DEPAKOTE / DEPAKOTE ER, sponsored by ABBVIE, on April 2, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is NDA 018723?
NDA 018723 is the application under which FDA issued this approval letter for DEPAKOTE / DEPAKOTE ER to ABBVIE. The letter is dated April 2, 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.