Orange Book product · Generic (ANDA)
ITRACONAZOLE
ITRACONAZOLE
At a glance
Sep 01, 2020
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 01, 2020
5 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ITRACONAZOLE
Strength
10MG/ML
Dosage form
SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 212239
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
- 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.
