Orange Book product · Brand (NDA)
SPORANOX
ITRACONAZOLE
At a glance
Mar 30, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 30, 1999
27 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
ITRACONAZOLE
Strength
10MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020966
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2018TOLSURABrand (NDA)
NDA 208901 · MAYNE PHARMA
- 2010ONMELBrand (NDA)
NDA 022484 · SEBELA IRELAND LTD
- 1997SPORANOXBrand (NDA)
NDA 020657 · JANSSEN PHARMS
- 1992SPORANOXBrand (NDA)
NDA 020083 · JANSSEN PHARMS
- 2020ITRACONAZOLEGeneric (ANDA)
ANDA 212239 · ANNORA PHARMA
- 2019ITRACONAZOLEGeneric (ANDA)
ANDA 208481 · APOTEX
- 2019ITRACONAZOLEGeneric (ANDA)
ANDA 206410 · STRIDES PHARMA
- 2018ITRACONAZOLEGeneric (ANDA)
ANDA 209460 · TORRENT
- 2017ITRACONAZOLEGeneric (ANDA)
ANDA 204672 · ZYDUS PHARMS
- 2017ITRACONAZOLEGeneric (ANDA)
ANDA 208591 · ALKEM LABS LTD
- 2017ITRACONAZOLEGeneric (ANDA)
ANDA 203445 · JUBILANT GENERICS
- 2016ITRACONAZOLEGeneric (ANDA)
ANDA 206741 · ALEMBIC
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.
