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FDA NDA · NDA021342

LEVOTHYROXINE SODIUM

Sponsor: CEDIPROF INC

APPLICATION
NDA021342
TYPE
NDA
ORIGINAL APPROVAL
2002-03-01
LATEST ACTION
2026-05-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL
LEVO-TPrescription
LEVOTHYROXINE SODIUM 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium · TABLET · ORAL

Approval history

2026-05-04Labeling · Supplement 28 · standard — Label ↗AP
2017-12-05Labeling · Supplement 23 · standard — Letter ↗AP
2017-01-12Manufacturing (CMC) · Supplement 25 · standardAP
2015-02-09Manufacturing (CMC) · Supplement 24 · standardAP
2012-11-20Manufacturing (CMC) · Supplement 22 · standardAP
2011-03-09Efficacy · Supplement 20 · standard — Letter ↗AP
2009-06-14Manufacturing (CMC) · Supplement 16 · standard — Label ↗AP
2008-06-10Labeling · Supplement 8 · standard — Label ↗AP
2008-06-10Labeling · Supplement 14 · standard — Letter ↗AP
2004-06-23Efficacy · Supplement 4 · standard — Review ↗AP
2004-06-23Efficacy · Supplement 3 · unknown — Review ↗AP
2003-12-08Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP
2003-08-21Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2002-03-01Type 5 - New Formulation or New Manufacturer · Original · standard — 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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