Orange Book product · Generic (ANDA)
FLUCONAZOLE
FLUCONAZOLE
At a glance
Sep 12, 2007
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 12, 2007
19 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUCONAZOLE
Strength
50MG/5ML
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
ANDA 077523
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FLUCONAZOLE
- 1993DIFLUCANBrand (NDA)
NDA 020090 · PFIZER
- 1992DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019950 · PFIZER
- 1990DIFLUCANBrand (NDA)
NDA 019949 · PFIZER
- 2026FLUCONAZOLEGeneric (ANDA)
ANDA 218692 · FDC LTD
- 2023FLUCONAZOLEGeneric (ANDA)
ANDA 209146 · LUPIN
- 2023FLUCONAZOLEGeneric (ANDA)
ANDA 215738 · ZHEJIANG POLY PHARM
- 2017FLUCONAZOLEGeneric (ANDA)
ANDA 208963 · ZYDUS PHARMS
- 2015FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 077909 · WOODWARD
- 2012FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078764 · HIKMA FARMACEUTICA
- 2012FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 078698 · HIKMA FARMACEUTICA
- 2011FLUCONAZOLEGeneric (ANDA)
ANDA 078423 · ANI PHARMS
- 2010FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINERGeneric (ANDA)
ANDA 077988 · WOODWARD
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.
