FDA NDA · NDA202231
LEVOTHYROXINE SODIUM
levothyroxine sodium anhydrous
Sponsor: FRESENIUS KABI USA
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APPLICATION
NDA202231
TYPE
NDA
ORIGINAL APPROVAL
2011-06-24
LATEST ACTION
2026-10-21
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 200MCG/VIAL · POWDER · INTRAVENOUS
LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 500MCG/VIAL · POWDER · INTRAVENOUS
LEVOTHYROXINE SODIUM · ReferencePrescription
LEVOTHYROXINE SODIUM 100MCG/VIAL · POWDER · INTRAVENOUS
Approval history
2026-10-21Labeling · Supplement 10 · standardAP
2014-06-04Manufacturing (CMC) · Supplement 6 · standardAP
2013-11-26Manufacturing (CMC) · Supplement 5 · standardAP
2013-02-16Manufacturing (CMC) · Supplement 4 · standardAP
2011-06-24Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Summary Review ↗AP
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