Orange Book product · Generic (ANDA)
NIZORAL
KETOCONAZOLE
At a glance
Nov 07, 1986
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 07, 1986
40 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOCONAZOLE
Strength
100MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 070767
Product number
001
Marketing status
DISCN
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.
