Active substance
Hydroxyurea
- US FDA 12
- Health Canada 4
- US price lines 1
- WHO EML 2
- Safety 3
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HYDREA | 500MG | capsule · oral | WAYLIS THERAP | Prescription | 7 Dec 1967 |
| DROXIA | 200MG; 300MG; 400MG | capsule · oral | WAYLIS THERAP | Prescription | 7 Dec 1967 |
| HYDROXYUREA | 500MG | capsule · oral | BARR | Prescription | 16 Oct 1998 |
| HYDROXYUREA | 500MG | capsule · oral | PH HEALTH | Prescription | 24 Feb 1999 |
| SIKLOS | 100MG; 1GM | tablet · oral | THERAVIA | Prescription | 21 Dec 2017 |
| HYDROXYUREA | 500MG | capsule · oral | LEADING | Prescription | 8 Apr 2020 |
| HYDROXYUREA | 500MG | capsule · oral | QILU | Prescription | 6 Mar 2024 |
| XROMI | 100MG/ML | solution · oral | NOVA LABS LTD | Prescription | 4 Apr 2024 |
| HYDROXYUREA | 500MG | capsule · oral | ROXANE | Discontinued | 18 Aug 1995 |
| HYDROXYUREA | 500MG; 250MG | capsule · oral | BARR LABS INC | Discontinued | 30 Jul 1998 |
| HYDROXYUREA | 250MG | capsule · oral | BARR | Discontinued | 16 Oct 1998 |
| HYDROXYUREA | 1GM | tablet · oral | BARR | Discontinued | 29 Aug 2000 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-HYDROXYUREA | 02247937 | 500 MG | CAPSULE · ORAL | APOTEX INC |
| HYDREA | 00465283 | 500 MG | CAPSULE · ORAL | CHEPLAPHARM ARZNEIMITTEL GMBH |
| MYLAN-HYDROXYUREA | 02242920 | 500 MG | CAPSULE · ORAL | MYLAN PHARMACEUTICALS ULC |
| RIVA-HYDROXYUREA | 02530260 | 500 MG | CAPSULE · ORAL | LABORATOIRE RIVA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | HYDROXYUREA 500 MG CAPSULE | $0.18364 | per EA | 23 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)
- 8.2.1. Cytotoxic medicines · complementary
Chronic myeloid leukaemia, not elsewhere classified
Oral > Solid > dosage form: 200 mg; 300 mg; 400 mg; 500 mg; 1 g; 100 mg (EMLc) - 10.3. Medicines for haemoglobinopathies · complementary
Other specified sickle cell disorders or other haemoglobinopathies
Oral > Solid > dosage form: 200 mg; 500 mg; 1 g; 100 mg (EMLc)
Safety signals and safety-related labeling changes
- US FDA 28 Nov 2023 DROXIA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Nov 2023 HYDREA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 28 Nov 2023 SIKLOS — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
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.