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FDA ANDA · ANDA076187

LEVOTHYROXINE SODIUM

Sponsor: MYLAN

APPLICATION
ANDA076187
TYPE
ANDA
ORIGINAL APPROVAL
2002-06-05
LATEST ACTION
2025-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-05-01Labeling · Supplement 53 · standardAP
2023-07-20Labeling · Supplement 50 · standardAP
2020-11-05Labeling · Supplement 32 · standardAP
2020-11-05Labeling · Supplement 38 · standardAP
2014-10-30Manufacturing (CMC) · Supplement 22AP
2014-10-09Manufacturing (CMC) · Supplement 28AP
2008-10-30Labeling · Supplement 18AP
2006-12-21Labeling · Supplement 8AP
2006-12-15Labeling · Supplement 7AP
2006-12-13Manufacturing (CMC) · Supplement 6AP
2005-03-22Labeling · Supplement 5AP
2004-07-13Supplement · Supplement 3 — Review ↗AP
2002-06-05Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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