Orange Book product · Generic (ANDA)
KETOCONAZOLE
KETOCONAZOLE
At a glance
May 20, 2021
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 20, 2021
5 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOCONAZOLE
Strength
2%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
ANDA 212443
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of KETOCONAZOLE
- 2007EXTINABrand (NDA)
NDA 021738 · RISING
- 2006XOLEGELBrand (NDA)
NDA 021946 · INA PHARMS
- 1997NIZORAL ANTI-DANDRUFFBrand (NDA)
NDA 020310 · KRAMER
- 1990NIZORALBrand (NDA)
NDA 019927 · JANSSEN PHARMS
- 1985NIZORALBrand (NDA)
NDA 019084 · JANSSEN PHARMA
- —NIZORALBrand (NDA)
NDA 018533 · JANSSEN PHARMS
- 2025KETOCONAZOLEGeneric (ANDA)
ANDA 219129 · NOVITIUM PHARMA
- 2025KETOCONAZOLEGeneric (ANDA)
ANDA 218559 · ZYDUS LIFESCIENCES
- 2024KETOCONAZOLEGeneric (ANDA)
ANDA 218498 · NOVITIUM PHARMA
- 2021KETOCONAZOLEGeneric (ANDA)
ANDA 215185 · PADAGIS US
- 2021KETOCONAZOLEGeneric (ANDA)
ANDA 213601 · XIROMED
- 2018KETOCONAZOLEGeneric (ANDA)
ANDA 210457 · STRIDES PHARMA
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.
