Orange Book product · Generic (ANDA)
ITRACONAZOLE
ITRACONAZOLE
At a glance
Dec 13, 2016
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 2016
9 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
ITRACONAZOLE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 205724
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of ITRACONAZOLE
- 2018TOLSURABrand (NDA)
NDA 208901 · MAYNE PHARMA
- 2010ONMELBrand (NDA)
NDA 022484 · SEBELA IRELAND LTD
- 1999SPORANOXBrand (NDA)
NDA 020966 · JANSSEN PHARMS
- 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
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.
