Sold as Delta-Cortef, Sterane, Meti-Derm. Every FDA application for this active ingredient: 3 branded and 51 generic.
As of Nov 14, 2026, FDA lists 54 applications for Prednisolone (sold as Delta-Cortef, Sterane, Meti-Derm), first approved Jun 21, 1955, with 0 new uses approved and 0 published complete response letters.
| Prednisolone Acetate | Part D | $156M | +1% | 2,231,768 |
| Prednisolone | Part D | $2.4M | +23% | 15,702 |
| Prednisolone Sodium Phosphate | Part D | $1.1M | +20% | 28,129 |
| Pred Mild | Part D | $681K | -7% | 1,705 |
| Pred Forte | Part D | $95K | -90% | 319 |
| Prednisolone Sodium Phos ODT | Part D | $24K | -65% | 63 |
| Orapred ODT | Part D | $18K | New | 0 |
| PrednIsolone | Part B | $8K | -24% | 309 |
| Millipred | Part D | $0K | -100% | 0 |
| Jun 21, 1955 | Delta-CortefNDA 9987 · New molecular entity | Pharmacia And Upjohn | 1 | Discontinued |
| Jul 1, 1955 | SteraneNDA 9996 · New formulation or manufacturer | Pfizer | 1 | Discontinued |
| Feb 24, 1956 | Meti-DermNDA 10209 · New dosage form | Schering | 3 | Discontinued |
| Nov 24, 1971 | PrednisoloneANDA 80327 | Roxane | 1 | Discontinued |
| Jan 17, 1972 | PrednisoloneANDA 80354 | Watson Labs | 12 | Marketed |
| Mar 24, 1972 | PrednisoloneANDA 80748 | Inwood Labs | 0 | Discontinued |
| May 9, 1972 | PrednisoloneANDA 80562 | Ferrante | 0 | Discontinued |
| Sep 6, 1972 | PrednisoloneANDA 80339 | Fosun Pharma | 16 | Discontinued |
| May 1, 1973 | PrednisoloneANDA 80358 | Sperti | 0 | Discontinued |
| Jun 20, 1973 | PrednisoloneANDA 80342 | Whiteworth Town Plsn | 2 | Discontinued |
| Jul 13, 1973 | PrednisoloneANDA 80780 | Impax Labs | 5 | Discontinued |
| May 31, 1974 | PrednisoloneANDA 80531 | Chartwell Molecular | 9 | Marketed |
| May 20, 1975 | PrednisoloneANDA 84439 | Everylife | 0 | Discontinued |
| Jun 17, 1975 | PrednisoloneANDA 84426 | Barr | 0 | Discontinued |
| Jun 29, 1976 | PrednisoloneANDA 85085 | Watson Labs | 13 | Discontinued |
| Mar 11, 1977 | PrednisoloneANDA 85416 | Watson Labs | 1 | Discontinued |
| Mar 14, 1977 | PrednisoloneANDA 85415 | Watson Labs | 1 | Discontinued |
| Feb 26, 1985 | PrednisoloneANDA 88892 | Superpharm | 0 | Discontinued |
| Feb 4, 1986 | PreloneANDA 89081 | Teva | 22 | Marketed |
| Jan 17, 1989 | PreloneANDA 89654 | Muro | 7 | Discontinued |
| Sep 16, 1994 | PrednisoloneANDA 84773 | Rising | 0 | Discontinued |
| May 28, 1998 | PrednisoloneANDA 40192 | We Pharms | 5 | Discontinued |
| May 13, 1999 | PrednisoloneANDA 40323 | Chartwell Rx | 3 | Marketed |
| May 28, 1999 | PrednisoloneANDA 40287 | Ivax Sub Teva Pharms | 8 | Discontinued |
| Jan 19, 2000 | PrednisoloneANDA 40322 | Teva Pharms | 1 | Discontinued |
| Oct 22, 2001 | PrednisoloneANDA 40423 | Nesher Pharms | 0 | Discontinued |
| Apr 10, 2002 | PrednisoloneANDA 40364 | Nesher Pharms | 0 | Discontinued |
| Feb 27, 2003 | PrednisoloneANDA 40401 | Hikma | 3 | Discontinued |
| Mar 5, 2003 | PrednisoloneANDA 40399 | Pharm Assoc | 2 | Discontinued |
| Sep 10, 2003 | PrednisoloneANDA 40313 | Pharmobedient Cnsltg | 3 | Discontinued |
| Aug 25, 2005 | PrednisoloneANDA 40571 | Pharm Assoc | 2 | Marketed |
| Aug 25, 2005 | PrednisoloneANDA 40570 | Pharm Assoc | 1 | Discontinued |
| Sep 21, 2007 | PrednisoloneANDA 40775 | Lannett Co Inc | 1 | Marketed |
| Mar 17, 2023 | PrednisoloneANDA 215673 | Aurobindo Pharma Ltd | 1 | Marketed |
| May 2, 2024 | PrednisoloneANDA 218083 | Zhejiang Xianju | 0 | Marketed |
| Jun 23, 2025 | PrednisoloneANDA 219509 | Tp Anda Holdings | 1 | Marketed |
| — | PrednisoloneANDA 80326 | Heather | 0 | Discontinued |
| — | PrednisoloneANDA 80398 | Teva | 0 | Discontinued |
| — | PrednisoloneANDA 80211 | Pvt Form | 0 | Discontinued |
| — | PrednisoloneANDA 80236 | Valeant Pharm Intl | 0 | Discontinued |
| — | CortaloneANDA 80304 | Halsey | 0 | Discontinued |
| — | PrednisoloneANDA 80307 | Marshall Pharma | 0 | Discontinued |
| — | PrednisoloneANDA 80322 | Phoenix Labs Ny | 0 | Discontinued |
| — | PrednisoloneANDA 80324 | West Ward | 0 | Discontinued |
| — | PrednisoloneANDA 80325 | Purepac Pharm | 0 | Discontinued |
| — | PrednisoloneANDA 80351 | Panray | 0 | Discontinued |
| — | PrednisoloneANDA 80378 | Ivax Sub Teva Pharms | 0 | Discontinued |
| — | PrednisoloneANDA 80534 | Vitarine | 0 | Discontinued |
| — | PrednisoloneANDA 80625 | Elkins Sinn | 0 | Discontinued |
| — | PrednisoloneANDA 83675 | Bundy | 0 | Discontinued |
| — | Fernisolone-PANDA 83941 | Ferndale Labs | 0 | Discontinued |
| — | PrednisoloneANDA 84542 | Chartwell Rx | 0 | Discontinued |
| — | PrednisoloneANDA 85170 | Tablicaps | 0 | Discontinued |
| — | PrednisoloneANDA 87987 | Udl | 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
Pfizer
Schering
Roxane
Impax Labs
Teva
Hikma