APPLICATION
ANDA200295
TYPE
ANDA
ORIGINAL APPROVAL
2012-11-29
LATEST ACTION
2025-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.025MG BASE · TABLET · ORAL
LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.05MG BASE · TABLET · ORAL
LIOTHYRONINE SODIUMPrescription
LIOTHYRONINE SODIUM EQ 0.005MG BASE · TABLET · ORAL
Approval history
2025-08-01Manufacturing (CMC) · Supplement 10 · standardAP
2025-06-12Labeling · Supplement 9 · standardAP
2019-12-23Labeling · Supplement 5 · standardAP
2012-11-29Not Applicable · OriginalAP
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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