Orange Book product · Brand (NDA)
ACZONE
DAPSONE
At a glance
Jul 07, 2005
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 07, 2005
21 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPSONE
Strength
5%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
NDA 021794
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2016ACZONEBrand (NDA)
NDA 207154 · ALMIRALL
- 2026DAPSONEGeneric (ANDA)
ANDA 220103 · ZYDUS LIFESCIENCES
- 2025DAPSONEGeneric (ANDA)
ANDA 218457 · AUROBINDO PHARMA LTD
- 2024DAPSONEGeneric (ANDA)
ANDA 213636 · TP ANDA HOLDINGS
- 2024DAPSONEGeneric (ANDA)
ANDA 214019 · ZYDUS LIFESCIENCES
- 2023DAPSONEGeneric (ANDA)
ANDA 212657 · CHARTWELL RX
- 2023DAPSONEGeneric (ANDA)
ANDA 215087 · CHARTWELL RX
- 2023DAPSONEGeneric (ANDA)
ANDA 215718 · ALEMBIC
- 2023DAPSONEGeneric (ANDA)
ANDA 209890 · AMNEAL
- 2023DAPSONEGeneric (ANDA)
ANDA 212383 · ENCUBE
- 2023DAPSONEGeneric (ANDA)
ANDA 207165 · RISING
- 2023DAPSONEGeneric (ANDA)
ANDA 213907 · TP ANDA HOLDINGS
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
