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FDA NDA · NDA021402

SYNTHROID

levothyroxine sodium

Sponsor: ABBVIE

APPLICATION
NDA021402
TYPE
NDA
ORIGINAL APPROVAL
2002-07-24
LATEST ACTION
2024-02-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2024-02-20Labeling · Supplement 38 · standard — Letter ↗AP
2022-08-30Labeling · Supplement 36 · standard — Letter ↗AP
2020-07-15Labeling · Supplement 34 · standard — Label ↗AP
2017-02-23Labeling · Supplement 28 · standard — Label ↗AP
2017-02-23Labeling · Supplement 24 · standard — Label ↗AP
2016-05-13Manufacturing (CMC) · Supplement 30 · standardAP
2015-11-25Manufacturing (CMC) · Supplement 29 · standardAP
2015-04-15Manufacturing (CMC) · Supplement 27 · standardAP
2014-05-27Manufacturing (CMC) · Supplement 25 · standardAP
2014-04-08Manufacturing (CMC) · Supplement 26 · standardAP
2011-01-14Labeling · Supplement 20 · unknown — Letter ↗AP
2008-07-14Labeling · Supplement 17 · standard — Label ↗AP
2008-04-20Labeling · Supplement 11 · standard — Label ↗AP
2002-07-24Type 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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