Orange Book product · Generic (ANDA)
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
FLUCONAZOLE
At a glance
Apr 20, 2015
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 20, 2015
11 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUCONAZOLE
Strength
100MG/50ML (2MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 077909
Product number
003
Marketing status
RX
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
- 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
- 2010FLUCONAZOLE IN SODIUM CHLORIDE 0.9%Generic (ANDA)
ANDA 077947 · BAXTER HLTHCARE CORP
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.
