FDA.reportPublic FDA data

Application 217495

Type
ANDA
Sponsor
XIROMED

Application Products#

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217495-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217495-001AP

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
2026-09-14 22:38:342026-08A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-2984e616aacf4f…
2026-08-18 06:07:402026-07A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-292680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217495-001LEVOTHYROXINE SODIUM100MCG/VIALPOWDER / INTRAVENOUSAP2024-11-29a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A217495-001AP184e616aacf4f…
2026-08-18 06:07:402026-07A217495-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A217495-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217495-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217495-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217495-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217495-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217495-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217495-001AP12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217495-001AP1a50c72e98297…

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 4 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack0b9d21d8-9b49-4fd2-b516-b25bc6a6b6712026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackcaf7825d-f434-472f-94f3-217a412555622026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.55cebc88-0514-4940-b974-ec7f0467d10e2026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.c7d5b71b-e983-4b1a-bfc2-d2343cf8668c2026-04-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP0235176b-ec39-44c4-a9e1-e0729a7989fa2026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP7d07e932-7372-4c17-aa53-55087107fa522026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack73c3d459-dcbf-4458-8edd-2637275a96a12026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack2ecaa38f-8a6f-4536-8033-251d2c52ae642026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack4461bc9f-35db-4211-82ab-7671cf4dc14b2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack66bb0ba9-cd63-4817-907f-7b8ad5dc66852026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Tirosint SOLLEVOTHYROXINE SODIUMIBSA Pharma Inc.5d378add-f13d-40f2-99dc-0f2340ab44b72026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsa0fa8fa5-d3bd-4e52-9ec5-5fb84702826d2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions70853a82-ba3b-4663-9f78-6791ca72ba9f2026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8ac112c3-1e06-4fdb-a7af-2ee988de5b152026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack69fb5cd6-90ba-487d-a754-07c664a1fdd12026-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
TirosintLEVOTHYROXINE SODIUMIBSA Pharma Inc.7a7ade79-0165-4e31-b84e-667416c00c7e2026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMYARAL Pharma Inc.d28d7202-1278-0486-e053-2995a90af2862026-03-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7c8a6441-3c12-46ae-bb3b-a320d80045b62026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions008de8fd-150f-4022-8ccb-c8bfa94875c72026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions991399a4-ff94-44d0-b1ba-1f89e77594982026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM

Reported adverse events (FAERS/openFDA)#

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