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 13 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levothyroxine sodiumLEVOTHYROXINE SODIUMNuCar Pharmaceuticals,Inc.a2194c58-b755-e6b5-e053-2a95a90a36d42024-06-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.1ac856d1-7067-a71d-e063-6294a90acc7c2024-06-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack56c633a9-3f64-46bd-b93f-afbff92b55592024-06-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMTeva Pharmaceuticals, Inc.60cadfd7-82b5-4207-97e1-1dd0655efb272024-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMDIRECT RXa5f15022-1166-09fe-e053-2a95a90aa2182024-05-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack8849620a-5e8d-4031-884f-9a2817b050f22024-05-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPe1b322a6-9161-45b9-bf77-3c44502d5efd2024-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMMylan Pharmaceuticals Inc.e95720f2-91c9-a6d0-f7d5-8bcb94d07bbc2024-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepacke486f83b-6cf0-4e7d-99ed-cfd19c4501e12024-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd35b5250-c26d-4d67-8a33-2f993b13e3e92024-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd6ce9798-7204-41df-9aeb-067000cb08952024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMMacleods Pharmaceuticals Limitedb8c20f76-3ee6-4b29-b77f-ed4ad1baaed92024-03-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
SynthroidLEVOTHYROXINE SODIUMAbbVie Inc.1e11ad30-1041-4520-10b0-8f9d30d30fcc2024-02-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions804d64c9-9804-4d6d-adb2-5036c0be8b5c2023-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions3e77de84-6f59-40ac-a1a4-7bfe303878232023-12-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP89df6a0f-6602-4c22-a052-b565ea8368a72023-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions60a0bc29-4283-4ae9-9173-5caf9266f7232023-11-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMA-S Medication Solutions970b8456-5b9a-4839-9222-4ec1302266e22023-11-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSSagent Pharmaceuticalsf57e9b19-6f17-4520-80fc-511322cc56c92023-10-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions59762069-5ea7-43d9-ba5b-8b250767b1462023-09-14Boxed 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