FDA.reportPublic FDA data

Application 016807

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001THYROLAR-0.25LIOTRIX (T4;T3)TABLET;ORAL0.0125MG;0.0031MGYesNo
002THYROLAR-2LIOTRIX (T4;T3)TABLET;ORAL0.1MG;0.025MGYesNo
003THYROLAR-3LIOTRIX (T4;T3)TABLET;ORAL0.15MG;0.0375MGYesNo
004THYROLAR-1LIOTRIX (T4;T3)TABLET;ORAL0.05MG;0.0125MGYesNo
005THYROLAR-0.5LIOTRIX (T4;T3)TABLET;ORAL0.025MG;0.0063MGYesNo
006THYROLAR-5LIOTRIX (T4;T3)TABLET;ORAL0.25MG;0.0625MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N016807-001THYROLAR-0.25LIOTRIX (T4;T3)0.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982
N016807-002THYROLAR-2LIOTRIX (T4;T3)0.1MG;0.025MGTABLET / ORALRLD, Approved before 1982
N016807-003THYROLAR-3LIOTRIX (T4;T3)0.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982
N016807-004THYROLAR-1LIOTRIX (T4;T3)0.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982
N016807-005THYROLAR-0.5LIOTRIX (T4;T3)0.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982
N016807-006THYROLAR-5LIOTRIX (T4;T3)0.25MG;0.0625MGTABLET / ORALApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 198284e616aacf4f…
2026-09-14 22:38:342026-08N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982b8a1b40f171c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0456-0040Thyrolarliothyronine sodium, LEVOTHYROXINE SODIUMAllergan, Inc.NDACurrent
0456-0045Thyrolarliothyronine sodium, LEVOTHYROXINE SODIUMAllergan, Inc.NDACurrent
0456-0050Thyrolarliothyronine sodium, LEVOTHYROXINE SODIUMAllergan, Inc.NDACurrent
0456-0055Thyrolarliothyronine sodium, LEVOTHYROXINE SODIUMAllergan, Inc.NDACurrent
0456-0060Thyrolarliothyronine sodium, LEVOTHYROXINE SODIUMAllergan, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
13037SUPPL2002-10-01