Orange Book product · Generic (ANDA)
DAPSONE
DAPSONE
At a glance
Feb 10, 2022
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 10, 2022
4 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
DAPSONE
Strength
7.5%
Dosage form
GEL
Route
TOPICAL
TE code
AB
Application
ANDA 214722
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DAPSONE
- 2016ACZONEBrand (NDA)
NDA 207154 · ALMIRALL
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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 215087 · CHARTWELL RX
- 2023DAPSONEGeneric (ANDA)
ANDA 215718 · ALEMBIC
- 2023DAPSONEGeneric (ANDA)
ANDA 209890 · AMNEAL
- 2023DAPSONEGeneric (ANDA)
ANDA 212383 · ENCUBE
- 2023DAPSONEGeneric (ANDA)
ANDA 207165 · RISING
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.
