Active substance
Dapsone
- SFDA 1
- US FDA 29
- Health Canada 2
- US price lines 6
- NHS prices 2
- WHO EML 1
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| Dapsone Tillomed | 50 mg | Tablet · Oral use | 28 Blister | SAR 212.70 | Generic · Prescription | Tillomed Laboratories Limited | Valid |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DAPSONE | 25MG | tablet · oral | EVEREST LIFE SCI | Prescription | 3 Jul 1979 |
| DAPSONE | 100MG | tablet · oral | EVEREST LIFE SCI | Prescription | 3 Jul 1979 |
| ACZONE | 5% | gel · topical | ALMIRALL | Prescription | 7 Jul 2005 |
| ACZONE | 7.5% | gel · topical | ALMIRALL | Prescription | 24 Feb 2016 |
| DAPSONE | 25MG; 100MG | tablet · oral | SOLIS PHARMS | Prescription | 6 May 2016 |
| DAPSONE | 25MG; 100MG | tablet · oral | NOVITIUM PHARMA | Prescription | 1 Dec 2016 |
| DAPSONE | 25MG; 100MG | tablet · oral | ACTAVIS LLC | Prescription | 23 Mar 2017 |
| DAPSONE | 5% | gel · topical | SUN PHARMA CANADA | Prescription | 16 Oct 2017 |
| DAPSONE | 100MG; 25MG | tablet · oral | RISING | Prescription | 8 May 2019 |
| DAPSONE | 7.5% | gel · topical | SUN PHARMA CANADA | Prescription | 26 Jun 2019 |
| DAPSONE | 7.5% | gel · topical | MYLAN | Prescription | 4 Feb 2022 |
| DAPSONE | 7.5% | gel · topical | TORRENT | Prescription | 10 Feb 2022 |
| DAPSONE | 5% | gel · topical | COSETTE PHARMS NC | Prescription | 31 Mar 2022 |
| DAPSONE | 5% | gel · topical | TP ANDA HOLDINGS | Prescription | 6 Jun 2023 |
| DAPSONE | 5% | gel · topical | ENCUBE | Prescription | 13 Oct 2023 |
| DAPSONE | 5% | gel · topical | AMNEAL | Prescription | 19 Oct 2023 |
| DAPSONE | 7.5% | gel · topical | ALEMBIC | Prescription | 27 Oct 2023 |
| DAPSONE | 7.5% | gel · topical | ZYDUS LIFESCIENCES | Prescription | 8 May 2024 |
| DAPSONE | 7.5% | gel · topical | TP ANDA HOLDINGS | Prescription | 26 Aug 2024 |
| DAPSONE | 5% | gel · topical | AUROBINDO PHARMA LTD | Prescription | 4 Apr 2025 |
| DAPSONE | 25MG; 100MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 26 Feb 2026 |
| DAPSONE | 5% | gel · topical | ALEMBIC | Prescription | 25 Jun 2026 |
| DAPSONE | 25MG; 100MG | tablet · oral | MACLEODS PHARMS | Prescription | 8 Jul 2026 |
| DAPSONE | 25MG; 100MG | tablet · oral | ALVOGEN | Discontinued | 7 Jan 2016 |
| DAPSONE | 25MG; 100MG | tablet · oral | CHARTWELL RX | Discontinued | 10 May 2016 |
4 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ACZONE | 02281074 | 5 % / W/W | GEL · TOPICAL | BAUSCH HEALTH, CANADA INC. |
| MAR-DAPSONE | 02481227 | 100 MG | TABLET · ORAL | MARCAN PHARMACEUTICALS INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | DAPSONE 100 MG TABLET | $0.80614 | per EA | 23 Sep 2026 |
| US NADAC | DAPSONE 25 MG TABLET | $0.45912 | per EA | 23 Sep 2026 |
| US NADAC | DAPSONE 5% GEL | $0.67503 | per GM | 23 Sep 2026 |
| US NADAC | DAPSONE 5% GEL | $0.6638 | per GM | 23 Sep 2026 |
| US NADAC | DAPSONE 7.5% GEL PUMP | $0.71521 | per GM | 23 Sep 2026 |
| US NADAC | DAPSONE 7.5% GEL PUMP | $0.79888 | per GM | 23 Sep 2026 |
| NHS Drug Tariff | Dapsone 100mg tablets | £13.80 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Dapsone 50mg tablets | £4.39 | 28 tablet | 1 Oct 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)
- 6.2.4. Antileprosy medicines · core
Leprosy
Oral > Solid: 100 mg tablet; 50 mg tablet; 25 mg tablet
Safety signals and safety-related labeling changes
- US FDA 10 Sep 2019 ACZONE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations - US FDA 18 May 2018 ACZONE — safety-related labeling change
Labeling sections changed: Adverse Reactions; 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.