Orange Book product · Brand (NDA)
NIZORAL ANTI-DANDRUFF
KETOCONAZOLE
At a glance
Oct 10, 1997
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 10, 1997
29 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
KETOCONAZOLE
Strength
1%
Dosage form
SHAMPOO
Route
TOPICAL
TE code
Not listed
Application
NDA 020310
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 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
- 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.
