FDA — authorised 10 May 2016
- Application: ANDA204074
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Aczone Gel in United States
FDA authorised Aczone Gel on 10 May 2016 · 11 US adverse-event reports
Marketing authorisations
FDA — authorised 23 March 2017
- Application: ANDA204380
- Marketing authorisation holder: ACTAVIS LLC
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2019
- Application: ANDA209430
- Marketing authorisation holder: TARO
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 May 2019
- Application: ANDA207165
- Marketing authorisation holder: RISING
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 2022
- Application: ANDA214722
- Marketing authorisation holder: TORRENT
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 31 May 2023
- Application: ANDA212701
- Marketing authorisation holder: AMNEAL
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 6 June 2023
- Application: ANDA213907
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 13 October 2023
- Application: ANDA212383
- Marketing authorisation holder: ENCUBE
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 27 October 2023
- Application: ANDA215718
- Marketing authorisation holder: ALEMBIC
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 8 May 2024
- Application: ANDA214019
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 August 2024
- Application: ANDA213636
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: DAPSONE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 February 2026
- Application: ANDA220103
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: DAPSONE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Aczone Gel, a tablet for oral administration, on 26 February 2026. The marketing authorisation holder is ZYDUS LIFESCIENCES. The product is indicated for a specific use, but the exact indication is not specified in the provided information. The approval was granted through the standard expedited pathway.
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 21 April 2025 – 21 April 2026
- Total reports: 11
Most-reported reactions
- Rash — 2 reports (18.18%)
- Abdominal Pain Upper — 1 report (9.09%)
- Abscess Limb — 1 report (9.09%)
- Acne — 1 report (9.09%)
- Arthropod Bite — 1 report (9.09%)
- Back Pain — 1 report (9.09%)
- Blood Glucose Decreased — 1 report (9.09%)
- Dizziness — 1 report (9.09%)
- Hallucination — 1 report (9.09%)
- Milia — 1 report (9.09%)
Other Dermatology approved in United States
Frequently asked questions
Is Aczone Gel approved in United States?
Yes. FDA authorised it on 10 May 2016; FDA authorised it on 23 March 2017; FDA authorised it on 1 March 2019.
Who is the marketing authorisation holder for Aczone Gel in United States?
CHARTWELL RX holds the US marketing authorisation.