FDA.reportPublic FDA data

Application 085931

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001A-HYDROCORTHYDROCORTISONE SODIUM SUCCINATEINJECTABLE;INJECTIONEQ 500MG 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
A085931-001A-HYDROCORTHYDROCORTISONE SODIUM SUCCINATEEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A085931-001A-HYDROCORTEQ 500MG BASE/VIALINJECTABLE / INJECTIONApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
generic name: HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEZydus Lifesciences Limitedd533ebee-9f1c-42d7-9808-ae5d5e55741b2026-05-08Name fallback
generic name: HYDROCORTISONE SODIUM SUCCINATE
Hydrocortisone sodium succinateHYDROCORTISONE SODIUM SUCCINATEZydus Pharmaceuticals USA Inc.37534164-9de5-4bb3-9f87-341dfcf908832026-05-08Warnings, Adverse reactionsName fallback
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
generic name: HYDROCORTISONE SODIUM SUCCINATE