Issued to SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD. Application meets requirements but marketing is blocked (patent/exclusivity).
Posted by FDA
August 25, 2026Application
NDA 505b1 • 218328
Product
NDA 218328
Company
SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD
Stage
Final Decision
Assyro regulatory brief
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FDA posted a tentative approval letter for NDA 218328 on 2026-08-25. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies NDA 218328 as an original application. 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
Not for marketing yet. FDA granted tentative approval to NDA 218328 for NDA 218328, meaning the application meets approval standards but patent or exclusivity protections block final approval. The product cannot be marketed until those conditions resolve and FDA issues final approval.
NDA 218328 is the application under which FDA issued this tentative approval letter to SEASONS BIOTECHNOLOGY (TAIZHOU) CO LTD. FDA posted the letter on August 25, 2026; the posting date is not the decision date.
The product cannot be marketed yet. Tentative approval means the application meets FDA approval standards, but patent or exclusivity protections block final approval. The sponsor typically requests final approval as the blocking date approaches, and FDA re-verifies that the approval conditions still hold before granting it.