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 3 of 15 · 281 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack775ef7ba-0b5b-40ba-ac7b-2aef121fe4f42026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack231fcdf8-c642-4074-8be8-53ee9c918f182026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack251e65e0-6925-4984-9df9-d6d7c6d0703c2026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack3142571d-f253-45e7-adc1-6ca80d34cab12026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack513d066a-2fcc-44ad-80e1-23c339a56ac62026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack741a8b30-86e1-4f37-917a-73265a82ee072026-05-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack1aaa327d-bb10-4815-8bd3-d8c9edc6c9db2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack64a663ac-ac02-4325-8f21-ee212e5461212026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC51b68266-95d2-c166-e063-6294a90a534f2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC50fe00b3-6610-1cac-e063-6294a90af8ac2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMCoupler LLC5100c561-0028-a3c0-e063-6394a90addeb2026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUMLEVOTHYROXINE SODIUMNuCare Pharmaceuticals,Inc.510349d0-6397-7e2b-e063-6394a90a8a682026-05-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LEVOTHYROXINE SODIUM
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMProficient Rx LPf94a81e2-49cd-430a-acda-1a47d5c5b59b2026-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMPreferred Pharmaceuticals Inc.4a2c8e57-d52d-409f-83d8-731b721bf6132026-04-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack4caf9040-5507-45a4-8f42-231aa925ab8d2026-04-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackf347d92a-7726-4165-bc3c-f5b37ec86f9f2026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine sodiumLEVOTHYROXINE SODIUMREMEDYREPACK INC.f8c14539-8ed1-406a-9b58-8ba3a7ce7ee32026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepack0210a600-747e-433a-8ba9-11692ecfb54a2026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackef7bc627-d37b-470e-b8f7-3c472c930d052026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Levothyroxine Sodium
generic name: LEVOTHYROXINE SODIUM
Levothyroxine SodiumLEVOTHYROXINE SODIUMBryant Ranch Prepackd0beda93-9454-4846-b5c6-2a9113fb17652026-04-07Boxed 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