Orange Book product · Generic (ANDA)
KETOCONAZOLE
KETOCONAZOLE
At a glance
Apr 25, 2000
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2000
26 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOCONAZOLE
Strength
2%
Dosage form
CREAM
Route
TOPICAL
TE code
AB
Application
ANDA 075581
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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
- 2021KETOCONAZOLEGeneric (ANDA)
ANDA 212443 · ENCUBE
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.
