Active ingredient
Dapsone
52 finished FDA listings contain Dapsone as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DAPSONE
- Dosage forms
- Gel, Tablet
- Routes
- Oral, Topical
- Manufacturers / labelers
- 30
- Strengths listed
- 100 mg/1 · 25 mg/1 · 50 mg/g · 75 mg/g
- Brand names in FDA listings
- Aczone, Dapsone, Dapsone 100 Mg, Dapsone 25 Mg
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3108
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| ANDA 086842 | EVEREST LIFE SCI | 1979-07-03 | 4 |
| ANDA 086841 | EVEREST LIFE SCI | 1979-07-03 | 6 |
| NDA 021794 | ALMIRALL | 2005-07-07 | 1 |
| NDA 207154 | ALMIRALL | 2016-02-24 | 1 |
| ANDA 203887 | SOLIS PHARMS | 2016-05-06 | 3 |
| ANDA 204074 | CHARTWELL RX | 2016-05-10 | 2 |
| ANDA 206505 | NOVITIUM PHARMA | 2016-12-01 | 2 |
| ANDA 209506 | SUN PHARMA CANADA | 2017-10-16 | 2 |
| ANDA 209430 | TARO | 2019-03-01 | 2 |
| ANDA 207165 | RISING | 2019-05-08 | 4 |
| ANDA 210191 | SUN PHARMA CANADA | 2019-06-26 | 2 |
| ANDA 213847 | MYLAN | 2022-02-04 | 1 |
| ANDA 214722 | TORRENT | 2022-02-10 | 2 |
| ANDA 210178 | COSETTE PHARMS NC | 2022-03-31 | 1 |
| ANDA 212701 | AMNEAL | 2023-05-31 | 1 |
| ANDA 213907 | TP ANDA HOLDINGS | 2023-06-06 | 1 |
| ANDA 212383 | ENCUBE | 2023-10-13 | 2 |
| ANDA 209890 | AMNEAL | 2023-10-19 | 1 |
| ANDA 215718 | ALEMBIC | 2023-10-27 | 2 |
| ANDA 214019 | ZYDUS LIFESCIENCES | 2024-05-08 | 2 |
| ANDA 213636 | TP ANDA HOLDINGS | 2024-08-26 | 1 |
| ANDA 218457 | AUROBINDO PHARMA LTD | 2025-04-04 | 1 |
| ANDA 220103 | ZYDUS LIFESCIENCES | 2026-02-26 | 4 |
| ANDA 213414 | ALEMBIC | 2026-06-25 | 2 |
| ANDA 218335 | MACLEODS PHARMS | 2026-07-08 | 2 |
Official labeling on DailyMed
- DAPSONE TABLET [MACLEODS PHARMACEUTICALS LIMITED] · version 1 · 2026-07-24
- DAPSONE GEL [ALEMBIC PHARMACEUTICALS LIMITED] · version 1 · 2026-07-13
- DAPSONE GEL [ALEMBIC PHARMACEUTICALS INC.] · version 3 · 2026-07-10
- DAPSONE GEL [AUROBINDO PHARMA LIMITED] · version 2 · 2026-05-20
- DAPSONE 100MG TABLET DAPSONE 25MG TABLET [SOLIS PHARMACEUTICALS INC.] · version 1 · 2026-05-13
- DAPSONE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-03-19
- DAPSONE TABLET [ZYDUS LIFESCIENCES LIMITED] · version 1 · 2026-03-02
- DAPSONE TABLET [VIONA PHARMACEUTICALS INC] · version 1 · 2026-03-02
- DAPSONE TABLET [RISING PHARMA HOLDINGS, INC.] · version 7 · 2026-01-30
- DAPSONE TABLET [AVKARE] · version 3 · 2026-01-14
- DAPSONE 25 MG (DAPSONE TABLETS) TABLET DAPSONE 100 MG (DAPSONE TABLETS) TABLET [EVEREST LIFE SCIENCES. LLC] · version 2 · 2026-01-08
- DAPSONE GEL [PACIFIC PHARMA, INC.] · version 6 · 2025-12-12
Showing the 12 most recent of 40 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.