FDA Orange Book · active-ingredient family
Tavaborole
Tavaborole is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:KERYDIN · NDA 204427
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KERYDINRLD | ANACOR PHARMS INC | NDA 204427 | — | Jul 07, 2014 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TAVABOROLE | ZYDUS LIFESCIENCES | ANDA 212294 | AB | Apr 10, 2023 | |
| TAVABOROLE | SUN PHARMA CANADA | ANDA 212215 | — | May 07, 2021 | |
| TAVABOROLE | CIPLA | ANDA 212224 | — | Feb 09, 2021 | |
| TAVABOROLE | LUPIN | ANDA 212168 | — | Feb 08, 2021 | |
| TAVABOROLE | CHARTWELL RX | ANDA 211963 | AB | Feb 03, 2021 | |
| TAVABOROLE | AMNEAL | ANDA 212256 | — | Nov 25, 2020 | |
| TAVABOROLE | ALEMBIC | ANDA 212188 | AB | Oct 21, 2020 | |
| TAVABOROLE | ENCUBE | ANDA 211297 | AB | Oct 13, 2020 | |
| TAVABOROLE | PADAGIS US | ANDA 211848 | — | Oct 13, 2020 |
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.
Tavaborole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
