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 12 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack2ee67e24-d72f-4419-a7d2-95bb44d9dd262024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackb57d0cc5-9fc7-496a-9bfa-417a288bb8252024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack68a6702d-ca0b-4e04-88a6-4accc8fb459e2024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepacke1f77539-2156-4890-baca-8b13779c745c2024-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMAmneal Pharmaceuticals NY LLCfca88c97-5cd4-4834-ba87-deb5bd6377882024-12-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.2646a481-09a5-af6a-e063-6394a90a16da2024-11-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLC152d071f-d4aa-46d2-b397-61c1cabdd86d2024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions924bb6e9-4b2b-406f-a0a8-376b1f22f1f52024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLCf88f44d8-2f18-4155-9d78-6323d19fbafe2024-10-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCarePharmaceuticals, Inc.2380859a-5b65-f88f-e063-6394a90aa4e22024-10-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LPb4f8dfd0-b15a-4da5-a0d0-ad768e0b7ff82024-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8f83fd60-5aa7-4e7f-a6e9-917e2c1abf272024-08-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd79526e0-d327-4545-a50c-99678766d8172024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackc22af2e0-fb36-4645-a911-3d293af5bd882024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.b1b8c5a4-8132-24d2-e053-2995a90a59ec2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMAurobindo Pharma Limitedc760d0cc-2245-4914-8c67-d536c41ac90f2024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.cba6bb77-2140-6cba-e053-2995a90aa1b62024-07-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMHikma Pharmaceuticals USA Inc.6279390b-ee61-4ef9-ac15-25537ca783c12024-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.a2157cf0-5c8f-7e69-e053-2a95a90aa0832024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.a215da96-acd9-6b8d-e053-2995a90a7e0d2024-06-20Boxed 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.