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FDA ANDA · ANDA207588

LEVOTHYROXINE SODIUM

Sponsor: WATSON LABS TEVA

APPLICATION
ANDA207588
TYPE
ANDA
ORIGINAL APPROVAL
2022-05-10
LATEST ACTION
2024-09-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

2024-09-10Labeling · Supplement 6 · standardAP
2023-08-08Labeling · Supplement 1 · standardAP
2022-05-10UNKNOWN · 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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