Application 020166

Type
NDA
Sponsor
US ARMY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SODIUM THIOSULFATESODIUM THIOSULFATEINJECTABLE;INJECTION250MG/MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020166-001SODIUM THIOSULFATESODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-143f01610625f2…
2019-09-15 20:21 UTC2019-09N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTION1992-02-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020166-001SODIUM THIOSULFATE250MG/MLINJECTABLE / INJECTIONRLD1992-02-14cb3db0bc1861…

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ThiosulfateSODIUM THIOSULFATEHope Pharmaceuticals82f55408-2de9-463d-85e8-b39c3b259f0b2026-05-26Warnings, Adverse reactionsName fallback
brand name: Sodium Thiosulfate
generic name: SODIUM THIOSULFATE
PEDMARKSODIUM THIOSULFATEFennec Pharmaceuticals Inc.f98c7076-2a7b-4fd7-ab90-eed5e9137bae2025-10-27Warnings, Adverse reactionsName fallback
generic name: SODIUM THIOSULFATE