Regulatory PathRegulatory requirements compared

Active substance

Danazol

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DANOL CAPS 100MG100 mgCapsule · Oral use60 BlisterSAR 108.65NCE · PrescriptionAVENTIS PHARMA LIMITEDWithdrawn by MAH · Not Marketed
DANOL CAPS 100MG100 mgCapsule · Oral use60 BlisterSAR 108.65NCE · PrescriptionAVENTIS PHARMA LIMITEDWithdrawn by MAH · Not Marketed
DANOL CAPS 200MG200 mgCapsule · Oral use60 BlisterSAR 206.20NCE · PrescriptionAVENTIS PHARMA LIMITEDWithdrawn by MAH · Not Marketed
DANOL CAPS 200MG200 mgCapsule · Oral use60 BlisterSAR 206.20NCE · PrescriptionAVENTIS PHARMA LIMITEDWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
DANAZOL200MG; 100MG; 50MGcapsule · oralBARRPrescription9 Aug 1996
DANAZOL200MG; 50MG; 100MGcapsule · oralLANNETT CO INCPrescription28 Sep 2005
DANAZOL50MG; 100MGcapsule · oralLANNETTPrescription19 Apr 2007
DANOCRINE200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**capsule · oralSANOFI AVENTIS USDiscontinued21 Jun 1976
DANAZOL200MGcapsule · oralAM THERAPDiscontinued

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
CYCLOMEN02018152100 MGCAPSULE · ORALSANOFI-AVENTIS CANADA INC
CYCLOMEN02018160200 MGCAPSULE · ORALSANOFI-AVENTIS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDANAZOL 100 MG CAPSULE$2.23171per EA23 Sep 2026
US NADACDANAZOL 200 MG CAPSULE$2.65221per EA23 Sep 2026
US NADACDANAZOL 50 MG CAPSULE$1.56444per EA22 Apr 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.

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.