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FDA NDA · NDA021116

LEVOTHYROXINE SODIUM

Sponsor: ALVOGEN

APPLICATION
NDA021116
TYPE
NDA
ORIGINAL APPROVAL
2002-10-24
LATEST ACTION
2023-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2023-11-16Labeling · Supplement 27 · standard — Label ↗AP
2022-04-14Efficacy · Supplement 23 · standard — Letter ↗AP
2021-12-13Efficacy · Supplement 21 · standard — Letter ↗AP
2019-04-23Labeling · Supplement 17 · standard — Label ↗AP
2017-08-31Labeling · Supplement 13 · standard — Letter ↗AP
2016-05-19Efficacy · Supplement 16 · standard — Letter ↗AP
2015-11-09Manufacturing (CMC) · Supplement 14 · standardAP
2015-01-13Labeling · Supplement 12 · standard — Review ↗AP
2006-03-10Labeling · Supplement 6 · standard — Letter ↗AP
2004-12-07Manufacturing (CMC) · Supplement 4 · standardAP
2002-10-24Type 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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