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 44.

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 7 of 7 · 264 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-001THYROLAR-0.250.0125MG;0.0031MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-002THYROLAR-20.1MG;0.025MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-003THYROLAR-30.15MG;0.0375MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-004THYROLAR-10.05MG;0.0125MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-005THYROLAR-0.50.025MG;0.0063MGTABLET / ORALRLD, Approved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N016807-006THYROLAR-50.25MG;0.0625MGTABLET / ORALApproved before 1982a50c72e98297…

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