Orange Book product · Brand (NDA)
NIZORAL
KETOCONAZOLE
At a glance
Dec 31, 1985
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 31, 1985
41 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOCONAZOLE
Strength
2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CREAM
Route
TOPICAL
TE code
Not listed
Application
NDA 019084
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2007EXTINABrand (NDA)
NDA 021738 · RISING
- 2006XOLEGELBrand (NDA)
NDA 021946 · INA PHARMS
- 1997NIZORAL ANTI-DANDRUFFBrand (NDA)
NDA 020310 · KRAMER
- 1990NIZORALBrand (NDA)
NDA 019927 · JANSSEN PHARMS
- —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
- 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.
