Regulatory PathRegulatory requirements compared

Active substance

Prednisone

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PREDONE 10MG TAB10 mgTablet · Oral use100 BlisterSAR 16.50NCE · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed
PREDONE 20MG TAB20 mgTablet · Oral use100 BlisterSAR 27.10NCE · PrescriptionWEST-WARDWithdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
PREDNISONE5MGtablet · oralWATSON LABSPrescription17 Jan 1972
PREDNISONE5MG; 1MG; 2.5MG; 10MG; 20MG; 50MGtablet · oralHIKMA PHARMSPrescription21 Apr 1972
PREDNISONE20MG; 5MG; 10MGtablet · oralMYLANPrescription26 Feb 1974
PREDNISONE20MGtablet · oralCHARTWELL MOLECULARPrescription27 Jun 1974
PREDNISONE20MGtablet · oralWATSON LABSPrescription11 Nov 1976
PREDNISONE10MGtablet · oralWATSON LABSPrescription12 Nov 1976
PREDNISONE5MG/5MLsolution · oralHIKMA PHARMSPrescription8 Nov 1984
PREDNISONE INTENSOL5MG/MLsolution · oralHIKMA PHARMSPrescription20 Feb 1985
PREDNISONE20MG; 5MG; 10MGtablet · oralSUN PHARM INDUSTRIESPrescription4 Dec 1985
PREDNISONE10MG; 5MG; 20MG; 2.5MG; 50MGtablet · oralJUBILANT CADISTAPrescription29 Aug 2001
PREDNISONE5MG; 10MGtablet · oralPH HEALTHPrescription12 Jul 2002
PREDNISONE20MGtablet · oralPH HEALTHPrescription12 Feb 2003
PREDNISONE2.5MGtablet · oralPH HEALTHPrescription21 Dec 2004
PREDNISONE1MGtablet · oralPH HEALTHPrescription21 Dec 2004
PREDNISONE1MGtablet · oralJUBILANT CADISTAPrescription6 Jun 2005
PREDNISONE2.5MG; 5MG; 10MG; 20MG; 50MGtablet · oralNOVITIUM PHARMAPrescription15 Nov 2019
PREDNISONE1MG; 5MGtablet · oralAMNEALPrescription16 Jun 2020
PREDNISONE10MG; 20MGtablet · oralAMNEALPrescription24 Jun 2020
PREDNISONE1MGtablet · oralSTRIDES PHARMAPrescription2 Sep 2020
PREDNISONE10MG; 20MG; 50MG; 2.5MG; 5MGtablet · oralSTRIDES PHARMAPrescription11 Feb 2021
PREDNISONE1MGtablet · oralNOVITIUM PHARMAPrescription6 Jul 2021
PREDNISONE1MGtablet · oralAUROBINDO PHARMA LTDPrescription16 Nov 2021
PREDNISONE2.5MG; 5MG; 10MG; 20MG; 50MGtablet · oralAUROBINDO PHARMA LTDPrescription28 Mar 2022
PREDNISONE5MG; 10MG; 20MGtablet · oralPOINTVIEW HLDINGSPrescription5 Dec 2023
PREDNISONE1MG; 2MGtablet, delayed release · oralDR REDDYSPrescription1 Oct 2025

98 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO PREDNISONE TAB 50MG0055095750 MGTABLET · ORALAPOTEX INC
APO PREDNISONE TAB 5MG003127705 MGTABLET · ORALAPOTEX INC
TEVA-PREDNISONE000216955 MGTABLET · ORALTEVA CANADA LIMITED
TEVA-PREDNISONE0023237850 MGTABLET · ORALTEVA CANADA LIMITED
WINPRED002713731 MGTABLET · ORALAA PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPREDNISONE 1 MG TABLET$0.03864per EA23 Sep 2026
US NADACPREDNISONE 10 MG TAB DOSE PACK$0.58481per EA23 Sep 2026
US NADACPREDNISONE 10 MG TABLET$0.05328per EA23 Sep 2026
US NADACPREDNISONE 2.5 MG TABLET$0.06607per EA23 Sep 2026
US NADACPREDNISONE 20 MG TABLET$0.06431per EA23 Sep 2026
US NADACPREDNISONE 5 MG TAB DOSE PACK$0.33674per EA23 Sep 2026
US NADACPREDNISONE 5 MG TABLET$0.03669per EA23 Sep 2026
US NADACPREDNISONE 5 MG/5 ML SOLUTION$0.4331per ML23 Sep 2026
US NADACPREDNISONE 5 MG/5 ML SOLUTION$0.60543per ML23 Sep 2026
US NADACPREDNISONE 50 MG TABLET$0.17117per EA23 Sep 2026
US NADACPREDNISONE INTENSOL 5 MG/ML$3.21489per ML23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.4. Hormones and antihormones · complementary
    Therapeutic equivalent to prednisolone for Lymphoid leukaemia, not elsewhere classified; Therapeutic equivalent to prednisolone for Diffuse large B-cell lymphoma, not otherwise specified; Therapeutic equivalent to prednisolone for Chronic lymphocytic leukaemia or small lymphocytic lymphoma; Therapeutic equivalent to prednisolone for Plasma cell myeloma; Therapeutic equivalent to prednisolone for Anaplastic large cell lymphoma, ALK-negative; Therapeutic equivalent to prednisolone for Anaplastic large cell lymphoma, ALK-positive; Therapeutic equivalent to prednisolone for Langerhans cell histiocytosis; Therapeutic equivalent to prednisolone for Hodgkin lymphoma; Therapeutic equivalent to prednisolone for Malignant neoplasms of prostate; Therapeutic equivalent to prednisolone for Follicular lymphoma
  • 3. Antiallergics and medicines used in anaphylaxis · core
    Therapeutic equivalent to prednisolone for Allergic or hypersensitivity conditions of unspecified type
  • 18.1. Adrenal hormones and synthetic substitutes · core
    Therapeutic equivalent to prednisolone for Adrenocortical insufficiency

Safety signals and safety-related labeling changes

All safety entries for prednisone →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.