FDA.reportPublic FDA data

Application 205366

Type
ANDA
Sponsor
PAR STERILE PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMPOWDER;INTRAVENOUS200MCG/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
A205366-001LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0784e616aacf4f…
2026-08-18 06:07:402026-07A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-073f01610625f2…
2019-09-15 20:21 UTC2019-09A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A205366-001LEVOTHYROXINE SODIUM200MCG/VIALPOWDER / INTRAVENOUS2015-12-07f41ea6bd6efb…

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 10 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMMajor Pharmaceuticals333642fd-93ae-4dc0-9c83-6d6b163c1c742025-06-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMAmerican Health Packaging38af4e36-b26b-485d-a6f3-7fbcf6072a0f2025-06-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf0680426-3581-400c-8ab5-5e6f18d0cabc2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsb4654497-c986-4792-9b6b-0a791c7c205b2025-06-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions0e0ad9f1-1f52-48ce-a996-79ebe7ad53cd2025-06-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions247f4d1d-6e65-4f81-a377-4dd88ae16dbb2025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMA-S Medication Solutions70dddaf0-f495-495f-95de-36e9efa2e3732025-05-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions91afb351-f067-49a2-bdf0-336ea209718d2025-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions237cc591-c40b-416f-ac00-96cd61bc59dc2025-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsfaaa1123-7515-46c2-abbb-b0615540c8cf2025-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions7f8ec438-8ddf-45d2-be94-ac032e1922292025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFosun Pharma USA Inc.3361138a-6e6f-e8df-e063-6294a90af2de2025-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSENDO USA, Inc.9d815416-11c9-470e-a82f-89b0bf232e122025-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutionsf5fc0f34-744c-4e03-ae9f-e017e40331392025-04-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSFresenius Kabi USA, LLCce990712-49c1-4f66-9ee4-c770e8ec394c2025-04-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions65b266af-72a5-4409-ab55-bd14341135aa2025-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions9ff5ad8e-f28c-4322-be6e-072487878c122025-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.30ccec8b-3f95-61c7-e063-6394a90a05a02025-03-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMLupin Pharmaceuticals, Inc.18717e58-89fb-4e2f-93b6-d6ac3e988d372025-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC08f4b1f8-6807-47e7-bef8-8d1972aa05572025-03-17Boxed 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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42023-161Levothyroxine SodiumLevothyroxine Sodium AnhydrousPar Pharmaceutical Companies, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40464ORIG2015-12-11
10439ORIG2015-12-09