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 1 of 15 · 287 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.bc9385d0-5c67-4bde-94da-e621347e2cba2026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.4c903249-69e9-4168-a9d1-22e6c2c1eb222026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6f25cbb3-0358-4778-b8f0-f76479a2dcc52026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.7fd988be-ab3d-406d-a55d-1e5a8a2101cc2026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.6108759a-783e-42ca-b078-6a3cd84ce9012026-09-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.13e03769-9a4f-497f-9afa-95bf525090b32026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNorthStar RxLLC58f4dc90-3648-49dc-a7e1-baf918a773b52026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNuCare Pharmaceuticals, Inc.597ea445-d926-adc6-e063-6394a90a64462026-08-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMAlvogen, Inc.4ddcaec1-a58f-340b-9bc1-bbe048b8c8852026-08-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUM ANHYDROUSONESOURCE SPECIALTY PHARMA LIMITEDae9954a5-e196-449c-abea-ebe4afbee5172026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f4c679-86cb-b97f-e063-6294a90ad5ef2026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC55f67831-4680-edbf-e063-6294a90a1d362026-07-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack489ffba8-983e-478f-8f62-fe08bf3d0e0b2026-06-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC544d67eb-8487-cb5d-e063-6394a90a31102026-06-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack3b282e57-1009-4d2c-8ca2-9cca9f7919372026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53e84179-fe2a-5696-e063-6394a90a85662026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMCoupler LLC5383a4d8-319a-5bf6-e063-6294a90a54972026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMNCS HealthCare of KY, LLC dba Vangard Labsabe173cc-1579-43a5-b12d-a31958d0a5392026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCardinal Health 107, LLC66a3bd4a-770b-4f67-bfa7-6d5e23f2ecbf2026-06-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC53316e75-9897-4935-e063-6294a90a94cf2026-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM

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