Orange Book product · Generic (ANDA)
DAPSONE
DAPSONE
At a glance
Oct 31, 2023
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 31, 2023
2 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPSONE
Strength
5%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
ANDA 215087
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPSONE
- 2016ACZONEBrand (NDA)
NDA 207154 · ALMIRALL
- 2005ACZONEBrand (NDA)
NDA 021794 · 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 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.
