Application 087532

Type
ANDA
Sponsor
INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 100MG BASE/VIALNoNo

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
A087532-001HYDROCORTISONE SODIUM SUCCINATEHYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19

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 UTC2026-02A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087532-001HYDROCORTISONE SODIUM SUCCINATEEQ 100MG BASE/VIALINJECTABLE / INJECTION1982-03-19cb3db0bc1861…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEApotex Corp.bfe185a6-b657-2fbb-4ac2-e085373f15f32026-07-28Warnings, Adverse reactionsName fallback
brand name: Hydrocortisone sodium succinate
generic name: HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEZydus Lifesciences Limitedd533ebee-9f1c-42d7-9808-ae5d5e55741b2026-05-08Name fallback
brand name: Hydrocortisone sodium succinate
generic name: HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEZydus Pharmaceuticals USA Inc.37534164-9de5-4bb3-9f87-341dfcf908832026-05-08Warnings, Adverse reactionsName fallback
brand name: Hydrocortisone sodium succinate
generic name: HYDROCORTISONE SODIUM SUCCINATE
Solu-CortefHYDROCORTISONE SODIUM SUCCINATEPharmacia & Upjohn Company LLC65eefd58-b166-4d71-ade6-45c8fdf869222025-09-05Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE SODIUM SUCCINATE
Solu-CortefHYDROCORTISONE SODIUM SUCCINATECardinal Health 107, LLCf5bb0854-a477-4e59-914b-eeeaef92a5962025-08-21Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE SODIUM SUCCINATE
Solu-CortefHYDROCORTISONE SODIUM SUCCINATEProPharma Distribution386942d3-c75f-25f1-e063-6394a90a5af22025-07-18Warnings, Adverse reactionsName fallback
generic name: HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATECipla USA Inc.451d6d04-b7d9-47d9-ba71-43cc5b9b30542024-09-24Warnings, Adverse reactionsName fallback
brand name: Hydrocortisone sodium succinate
generic name: HYDROCORTISONE SODIUM SUCCINATE