Orange Book product · Generic (ANDA)
EFINACONAZOLE
EFINACONAZOLE
At a glance
Feb 23, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 23, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
EFINACONAZOLE
Strength
10%
Dosage form
SOLUTION
Route
TOPICAL
TE code
AB
Application
ANDA 212027
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EFINACONAZOLE
- 2014JUBLIABrand (NDA)
NDA 203567 · BAUSCH
- 2022EFINACONAZOLEGeneric (ANDA)
ANDA 212178 · ZYDUS LIFESCIENCES
- 2022EFINACONAZOLEGeneric (ANDA)
ANDA 212169 · LUPIN
- 2021EFINACONAZOLEGeneric (ANDA)
ANDA 211969 · NIVAGEN PHARMS INC
- 2021EFINACONAZOLEGeneric (ANDA)
ANDA 212066 · AUROBINDO PHARMA LTD
- 2020EFINACONAZOLEGeneric (ANDA)
ANDA 211851 · PADAGIS US
- 2020EFINACONAZOLEGeneric (ANDA)
ANDA 211827 · TEVA PHARMS USA
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.
