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 8 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCda827567-810b-624d-e053-2a95a90a9bde2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCf86fab39-bbd9-a51c-e053-6294a90accd02026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNorthwind Health Company, LLCd9dff641-ced3-bae3-e053-2a95a90a2e292026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC472ec9e7-c1db-bf8c-e063-6394a90a2c072025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionse3667ab1-2bd9-4e0d-8a97-f907593e79542025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionseb120047-a43b-40a4-9f55-067b1b51edda2025-12-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions2adb05ef-b3fa-4ac2-b219-99442746392b2025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutionsd5b005e8-a88d-450b-bbc3-393d885260f52025-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsc29a417b-95b0-4c9b-85e6-ec884049edb12025-12-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions3453af75-8c2e-421f-9a08-24751936df412025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions1af49c9f-93da-4838-899b-9445083a154b2025-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsfea284d8-0514-498b-a37c-405730b5f6a22025-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC4302e36f-0b5b-f645-e063-6394a90a010f2025-11-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutionseb149423-070f-49ae-ab18-5afee09d06fb2025-11-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack48c29432-a36c-4787-a05f-8d25a0abcc372025-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMAccord Healthcare Inc.a6233381-3043-4e9a-aaa6-a6b105e5142b2025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPbcf10012-8920-4737-92f5-7401ee0c58942025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP00a4fc0b-7162-455e-8ed3-56efdbbe182e2025-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMPiramal Critical Care, Inc.76139990-1355-cfb6-e053-2991aa0ace5b2025-09-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMZydus Pharmaceuticals USA Inc.bf8a952c-f05b-4814-b55a-ed04be0152692025-09-16Boxed 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.