APPLICATION
NDA016807
TYPE
NDA
ORIGINAL APPROVAL
1969-11-21
LATEST ACTION
2014-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
THYROLAR-1 · ReferenceDiscontinued
LIOTRIX (T4 0.05MG, T3) 0.0125MG · TABLET · ORAL
THYROLAR-2 · ReferenceDiscontinued
LIOTRIX (T4 0.1MG, T3) 0.025MG · TABLET · ORAL
THYROLAR-0.5 · ReferenceDiscontinued
LIOTRIX (T4 0.025MG, T3) 0.0063MG · TABLET · ORAL
THYROLAR-3 · ReferenceDiscontinued
LIOTRIX (T4 0.15MG, T3) 0.0375MG · TABLET · ORAL
THYROLAR-0.25 · ReferenceDiscontinued
LIOTRIX (T4 0.0125MG, T3) 0.0031MG · TABLET · ORAL
THYROLAR-5Discontinued
LIOTRIX (T4 0.25MG, T3) 0.0625MG · TABLET · ORAL
Approval history
2014-01-14Manufacturing (CMC) · Supplement 33 · standardAP
2002-12-13Manufacturing (CMC) · Supplement 26 · standardAP
2001-06-08Manufacturing (CMC) · Supplement 24 · standardAP
1999-05-17Manufacturing (CMC) · Supplement 23 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 22 · standardAP
1990-04-16Labeling · Supplement 21AP
1989-03-06Manufacturing (CMC) · Supplement 20 · standardAP
1987-04-17Manufacturing (CMC) · Supplement 19 · standardAP
1985-05-08Labeling · Supplement 18AP
1982-12-14Manufacturing (CMC) · Supplement 17 · standardAP
1980-10-15Manufacturing (CMC) · Supplement 14 · standardAP
1980-08-12Manufacturing (CMC) · Supplement 13 · standardAP
1980-01-08Labeling · Supplement 12AP
1979-04-12Labeling · Supplement 11AP
1975-06-26Manufacturing (CMC) · Supplement 4 · standardAP
1975-06-26Manufacturing (CMC) · Supplement 2 · standardAP
1975-06-26Labeling · Supplement 3AP
1975-06-26Labeling · Supplement 1AP
1969-11-21Type 5 - New Formulation or New Manufacturer · Original · standardAP
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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