← FDA DRUG APPROVALS

FDA NDA · NDA021292

EUTHYROX

levothyroxine sodium

Sponsor: EMD SERONO INC

APPLICATION
NDA021292
TYPE
NDA
ORIGINAL APPROVAL
2002-05-31
LATEST ACTION
2022-04-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2022-04-27Labeling · Supplement 10 · standard — Letter ↗AP
2018-09-14Labeling · Supplement 5 · standard — Label ↗AP
2018-09-14Labeling · Supplement 6 · standard — Label ↗AP
2018-09-14Efficacy · Supplement 4 · standard — Label ↗AP
2009-03-26Labeling · Supplement 2 · standard — Letter ↗AP
2002-05-31Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
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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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