Issued to MYLAN. Application is approved as submitted.
Posted by FDA
July 22, 2026Application
ANDA 505j • 217769
Product
FERRIC CARBOXYMALTOSE
Company
MYLAN
Stage
Final Decision
Assyro regulatory brief
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FDA posted an approval letter for FERRIC CARBOXYMALTOSE on 2026-07-22. This is the document posting date; consult the signed letter for the decision date. The source metadata identifies ANDA 217769 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
This letter documents an FDA approval action: FDA approved ANDA 217769 for FERRIC CARBOXYMALTOSE, sponsored by MYLAN,. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
ANDA 217769 is the application under which FDA issued this approval letter for FERRIC CARBOXYMALTOSE to MYLAN. FDA posted the letter on July 22, 2026; the posting date is not the decision date.
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.