Orange Book product · Brand (NDA)
DIFLUCAN
FLUCONAZOLE
At a glance
Jan 29, 1990
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 29, 1990
36 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FLUCONAZOLE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 019949
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1993DIFLUCANBrand (NDA)
NDA 020090 · PFIZER
- 1992DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERBrand (NDA)
NDA 019950 · 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
- 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.
