Orange Book product · Brand (NDA)
KERYDIN
TAVABOROLE
At a glance
Jul 07, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 07, 2014
12 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
TAVABOROLE
Strength
5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
NDA 204427
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2023TAVABOROLEGeneric (ANDA)
ANDA 212294 · ZYDUS LIFESCIENCES
- 2021TAVABOROLEGeneric (ANDA)
ANDA 212215 · SUN PHARMA CANADA
- 2021TAVABOROLEGeneric (ANDA)
ANDA 212224 · CIPLA
- 2021TAVABOROLEGeneric (ANDA)
ANDA 212168 · LUPIN
- 2021TAVABOROLEGeneric (ANDA)
ANDA 211963 · CHARTWELL RX
- 2020TAVABOROLEGeneric (ANDA)
ANDA 212256 · AMNEAL
- 2020TAVABOROLEGeneric (ANDA)
ANDA 212188 · ALEMBIC
- 2020TAVABOROLEGeneric (ANDA)
ANDA 211297 · ENCUBE
- 2020TAVABOROLEGeneric (ANDA)
ANDA 211848 · PADAGIS US
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.
