Orange Book product · Generic (ANDA)
EFINACONAZOLE
EFINACONAZOLE
At a glance
Mar 02, 2022
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 02, 2022
4 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
EFINACONAZOLE
Strength
10%
Dosage form
SOLUTION
Route
TOPICAL
TE code
Not listed
Application
ANDA 212169
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of EFINACONAZOLE
- 2014JUBLIABrand (NDA)
NDA 203567 · BAUSCH
- 2026EFINACONAZOLEGeneric (ANDA)
ANDA 212027 · ALEMBIC
- 2022EFINACONAZOLEGeneric (ANDA)
ANDA 212178 · ZYDUS LIFESCIENCES
- 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.
