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 6 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCffc34bc6-5de5-addb-e053-6294a90a25be2026-01-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.49136b34-1bc1-ec4e-e063-6394a90ac9dd2026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf2bed4e7-86e9-430e-80d9-7bd7cfcf9bf52026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions8f7dc71e-4a48-4ba5-945b-f340ff51636e2026-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions36af0286-e447-4098-b3f2-772debd586672026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse8142948-2bde-4f4b-931e-da43e91f2d592026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd29bc0fd-5587-4a70-a505-f5aee1f115a62026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsd5b11dac-1acd-4aa2-b837-e3b90d4f69222026-01-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf6c92836-95e1-1402-e053-6394a90a2f5e2026-01-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse2291336-1188-48f4-af52-d12ac892f80f2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions98d7ce2b-a248-4ed0-a2ec-d28ba623531e2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.59a99739-2da5-46a7-8811-1169123bed9b2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.579b1935-77f5-4381-9cb0-e0130e4834e82026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals, Inc.4e6dce46-cbf5-4353-9d0c-36b6f857197a2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMLannett Company, Inca8db0f7d-8863-9309-e053-2995a90a284a2026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.3d737f79-7fc9-4221-e063-6394a90ac9aa2026-01-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc968836a-f94c-4d13-e053-2995a90a8df52026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb10e666-6204-56cc-e053-2995a90a9e082026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCdb5dd9d2-4f96-25d0-e053-2995a90af9dc2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCc9f4923e-5625-1d4f-e053-2a95a90aabc92026-01-01Boxed 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.