Issued to CHEPLAPHARM. Application is approved as submitted.
Issued
February 3, 2026Application
NDA 505b1 • 020592
Product
ZYPREXA / ZYPREXA ZYDIS / ZYPREXA RELPREVV
Company
CHEPLAPHARM
Stage
Final Decision
Assyro regulatory brief
FreeSource facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
FDA issued an approval letter for ZYPREXA, ZYPREXA ZYDIS, ZYPREXA RELPREVV on 2026-02-03. The source metadata identifies NDA 020592, NDA 021086, NDA 021253, NDA 022173 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
Open the document workspaceFDA source document
This letter documents an FDA approval action: FDA approved NDA 020592 for ZYPREXA / ZYPREXA ZYDIS / ZYPREXA RELPREVV, sponsored by CHEPLAPHARM, on February 3, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
NDA 020592 is the application under which FDA issued this approval letter for ZYPREXA / ZYPREXA ZYDIS / ZYPREXA RELPREVV to CHEPLAPHARM. The letter is dated February 3, 2026.
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.