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FDA ANDA · ANDA210831

LEVOTHYROXINE SODIUM

Sponsor: AMNEAL

APPLICATION
ANDA210831
TYPE
ANDA
ORIGINAL APPROVAL
2019-02-19
LATEST ACTION
2024-08-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.3MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.088MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.175MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.05MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.15MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.125MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.1MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.2MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.075MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.025MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.137MG · TABLET · ORAL
LEVOTHYROXINE SODIUMDiscontinued
LEVOTHYROXINE SODIUM 0.112MG · TABLET · ORAL

Approval history

2024-08-26Labeling · Supplement 4 · standardAP
2023-08-29Labeling · Supplement 3 · standardAP
2023-08-29Labeling · Supplement 2 · standardAP
2019-02-19UNKNOWN · Original · standardAP
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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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