Issued to SANDOZ INC. Application meets requirements but marketing is blocked (patent/exclusivity).
Posted by FDA
July 21, 2026Application
ANDA 505j • 219346
Product
ANDA 219346
Company
SANDOZ INC
Stage
Final Decision
Assyro regulatory brief
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FDA posted a tentative approval letter for ANDA 219346 on 2026-07-21. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 219346 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 ANDA 219346 for ANDA 219346, 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.
ANDA 219346 is the application under which FDA issued this tentative approval letter to SANDOZ INC. FDA posted the letter on July 21, 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.