TheraRadar
Data updated: May 26, 2026

HYDROCORTISONE SODIUM SUCCINATE

Respiratory Approved 1981-05-28
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
44
Years on Market

Details

Status
Discontinued
First Approved
1981-05-28
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

WATSON LABS INTL MEDICATION Baxter ABRAXIS PHARM Apotex ZYDUS PHARMS Cipla
Active Ingredient: HYDROCORTISONE SODIUM SUCCINATE

HYDROCORTISONE SODIUM SUCCINATE Approval History

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Original
New Indication
New Form
Label Update
25 FDA actions from 1981 to 2026
May 2026 ORIGINAL
Update
Feb 2026 ORIGINAL
Update
Sep 2024 ORIGINAL
Update

What HYDROCORTISONE SODIUM SUCCINATE Treats

4 FDA approvals

Originally approved for its first indication in 1981 . Covers 4 distinct patient populations.

  • Other (4)
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Clinical Trial Registry

8 trials
Trial Sponsor ID Phase Status Title
NCT02112916 results posted NCI-2014-00712 NCI-2014-00712, s14-01925 Ph 3 active not recruiting Combination Chemotherapy With or Without Bortezomib in Treating Younger Patients With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia or Stage II-IV T-Cell Lymphoblastic Lymphoma
NCT02883049 results posted NCI-2011-03797 NCI-2011-03797, S12-01254 Ph 3 active not recruiting Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leukemia and Ph-Like TKI Sensitive Mutations
NCT05761171 AALL2121 NCI-2023-00503, AALL2121 Ph 2 active not recruiting A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
NCT06247787 PEPN2312 NCI-2023-11026, PEPN2312 Ph 1 recruiting A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine and Cytarabine for Patients With AML, MDS or JMML That Has Come Back or Does Not Respond to Therapy
NCT04546399 NCI-2020-06813 NCI-2020-06813, AALL1821 Ph 2 recruiting A Study to Compare Blinatumomab Alone to Blinatumomab With Nivolumab in Patients Diagnosed With First Relapse B-Cell Acute Lymphoblastic Leukemia (B-ALL)
NCT02828358 results posted NCI-2016-00973 NCI-2016-00973, s17-00488 Ph 2 completed Azacitidine and Combination Chemotherapy in Treating Infants With Acute Lymphoblastic Leukemia and KMT2A Gene Rearrangement
NCT05320380 APAL2020B NCI-2022-02157, APAL2020B Ph 1, Ph 2 withdrawn A Study of the Drug IMGN632 in Children With Leukemia That Has Come Back After Treatment or is Difficult to Treat
NCT00720109 results posted NCI-2009-00312 NCI-2009-00312, AALL0622 Ph 2, Ph 3 completed Dasatinib and Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

HYDROCORTISONE SODIUM SUCCINATE FDA Label Details

Looking for the branded version?

SOLU-CORTEF

Full clinical data, patents, trials, and competitive landscape for hydrocortisone sodium succinate.

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Data Sources

FDA Approval: ANDA084748 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.