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 14 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine SodiumLEVOTHYROXINE SODIUMA-S Medication Solutions8bc641d8-0185-49b2-9c1f-d886bf5ce0982023-08-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMXLCare Pharmaceuticals, Inc.51a27110-e787-409b-98ba-c6471d0ad5cf2023-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMCamber Pharmaceuticals, Inc.b1ba1c7d-371a-4aa8-bee8-dd29b5e7da7e2023-01-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP2f129a3d-f3e6-45b2-9704-3ad171cbd8a52022-08-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP329b6eb2-4fa3-41f6-a6ff-96d94b7a65bf2022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP9d1aaa2d-c8c0-478f-8540-f92f6512cfcb2022-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPca197216-83f1-470a-9313-d1b9239246612022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP7ceed5ff-fd41-4ebd-ade7-e31b135231c12022-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP2daab9ce-0570-4fdf-a7bd-01c3178f8cf32021-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP2f0657d5-3e5c-4249-bfaa-7f5ef15286722021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOXYLLEVOTHYROXINE SODIUMPfizer Laboratories Div Pfizer Inc758588c3-c63e-491b-0aa2-4f50d80cb1742020-12-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC388a1f15-8c1c-46a5-997f-7f326f696b592020-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMFresenius Kabi USA, LLC50b1c8a4-75b6-49c8-80fc-3841ee80b1832020-12-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP12ccf2fd-ccf0-4bcf-8eee-e2a16c8b44d62020-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP97e28b00-9913-463f-9de2-08c828edbe672020-03-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP05ab038e-45fa-488e-a05e-12a2dd3564c12020-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPb81720f9-2836-4c1d-8691-0f6acef133162020-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
levothyroxine sodiumLEVOTHYROXINE SODIUMProficient Rx LP3019762c-d480-4530-a3b2-762b523e79612019-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP434075d5-a82b-4f17-85e6-4c1922663dbc2019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LP18c7c63a-642e-47fe-a8ee-12aaf652b2aa2019-10-01Boxed 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