Sold as Cortone, Cortisone Acetate. Every FDA application for this active ingredient: 5 branded and 15 generic.
As of Nov 15, 2026, FDA lists 20 applications for Cortisone Acetate (sold as Cortone, Cortisone Acetate), first approved Jun 13, 1950, with 0 new uses approved and 0 published complete response letters.
| Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerMetastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · ECOG-ACRIN Cancer Research Group | Phase 2 / Phase 3 | Not yet recruiting | Oct 1, 2026 |
| Success Rates and Safety of Steroid Injections in Managing Spinal and Sacro-Iliac Pain (CORTisone Injection Spine Study)Back Pain Lower Back, Neck Pain · Igor Wilderman. MD | Phase 4 | Recruiting | Aug 13, 2026 |
| Testing the Addition of a New Anti-Cancer Drug, Glofitamab to Usual Chemotherapy for Burkitt and Double Hit LymphomaRecurrent Burkitt Lymphoma, Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 Rearrangements · National Cancer Institute (NCI) | Phase 2 / Phase 3 | Not yet recruiting | Jul 24, 2026 |
| Epcoritamab and Pola-R-mini-CHP for the Treatment of Diffuse Large B Cell Lymphoma in Elderly or Unfit PatientsDiffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma · Jonsson Comprehensive Cancer Center | Phase 1 | Not yet recruiting | Jul 20, 2026 |
| Epcoritamab in Combination With Dose Adjusted EPOCH-R for High-risk Burkitt Lymphoma (BL), The BEDROCK StudyAdult Burkitt Lymphoma · AIDS Malignancy Consortium | Phase 2 | Not yet recruiting | Jun 23, 2026 |
| Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE TrialRecurrent Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 · Mayo Clinic | Phase 2 | Recruiting | Jun 16, 2026 |
| AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified · National Cancer Institute (NCI) | Phase 1 | Recruiting | Jun 16, 2026 |
| Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell LymphomaAnn Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma · National Cancer Institute (NCI) | Phase 1 | Not yet recruiting | Mar 3, 2026 |
| Jun 13, 1950 | CortoneNDA 7110 · New molecular entity | Merck | 7 | Discontinued |
| Dec 4, 1950 | CortoneNDA 7750 · New dosage form | Merck | 9 | Discontinued |
| Nov 2, 1951 | Cortisone AcetateNDA 8126 · New formulation or manufacturer | Pharmacia And Upjohn | 5 | Discontinued |
| Jan 14, 1952 | Cortisone AcetateNDA 8284 · New formulation or manufacturer | Panray | 1 | Discontinued |
| Jan 3, 1972 | Cortisone AcetateANDA 80630 | Ivax Sub Teva Pharms | 0 | Discontinued |
| Jun 13, 1972 | Cortisone AcetateANDA 80776 | Hikma | 21 | Discontinued |
| Jun 20, 1973 | Cortisone AcetateANDA 80341 | Whiteworth Town Plsn | 0 | Discontinued |
| Jul 9, 1973 | Cortisone AcetateANDA 83536 | Ivax Sub Teva Pharms | 0 | Discontinued |
| Aug 31, 1973 | Cortisone AcetateANDA 83471 | Barr | 0 | Discontinued |
| Oct 17, 1974 | Cortisone AcetateANDA 80694 | Chartwell Molecular | 1 | Discontinued |
| Jan 22, 1975 | Cortisone AcetateANDA 84246 | Everylife | 0 | Discontinued |
| Mar 7, 1978 | Cortisone AcetateANDA 85677 | Watson Labs | 0 | Discontinued |
| May 15, 1978 | Cortisone AcetateANDA 85884 | Watson Labs | 18 | Discontinued |
| Sep 17, 2001 | Cortisone AcetateNDA 9458 · New formulation or manufacturer | Impax Labs | 42 | Discontinued |
| — | Cortisone AcetateANDA 80333 | Vitarine | 0 | Discontinued |
| — | Cortisone AcetateANDA 80493 | Purepac Pharm | 0 | Discontinued |
| — | Cortisone AcetateANDA 80731 | Inwood Labs | 0 | Discontinued |
| — | Cortisone AcetateANDA 80836 | Elkins Sinn | 0 | Discontinued |
| — | Cortisone AcetateANDA 83147 | Watson Labs | 0 | Discontinued |
| — | Cortisone AcetateANDA 85736 | Heather | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma
Impax Labs