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FDA NDA · NDA202231

LEVOTHYROXINE SODIUM

levothyroxine sodium anhydrous

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA202231
TYPE
NDA
ORIGINAL APPROVAL
2011-06-24
LATEST ACTION
2026-07-06
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

2026-07-06Labeling · Supplement 11 · standard — Label ↗AP
2014-06-04Manufacturing (CMC) · Supplement 6 · standardAP
2013-11-26Manufacturing (CMC) · Supplement 5 · standardAP
2013-02-16Manufacturing (CMC) · Supplement 4 · standardAP
2012-12-20Labeling · Supplement 3 · standard — Letter ↗AP
2011-06-24Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Summary Review ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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