FDA.reportPublic FDA data

Application 216729

Type
ANDA
Sponsor
ONESOURCE SPECIALTY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS100MCG/VIALNoNo
002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS200MCG/VIALNoNo
003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS500MCG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216729-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05
A216729-002LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05
A216729-003LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A216729-001AP
A216729-002AP
A216729-003AP

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-002LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-003LEVOTHYROXINE SODIUM500MCG/VIALPOWDER / INTRAVENOUSAP2025-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216729-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216729-002AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216729-003AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-002AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216729-003AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216729-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216729-002AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216729-003AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-002AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216729-003AP1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-001AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-002AP1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216729-003AP1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSONESOURCE SPECIALTY PHARMA LIMITEDae9954a5-e196-449c-abea-ebe4afbee5172026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216729
application number: ANDA216729
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFosun Pharma USA Inc.3361138a-6e6f-e8df-e063-6294a90af2de2025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216729
application number: ANDA216729