FDA — authorised 29 July 2004
- Application: ANDA076507
- Marketing authorisation holder: TARO
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Diflucan in United States
FDA authorised Diflucan on 29 July 2004
Marketing authorisations
FDA — authorised 29 July 2004
- Application: ANDA076213
- Marketing authorisation holder: ROXANE
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076332
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076304
- Marketing authorisation holder: HOSPIRA
- Local brand name: FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076145
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076246
- Marketing authorisation holder: HIKMA
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076087
- Marketing authorisation holder: HIKMA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076086
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076077
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 2005
- Application: ANDA076888
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 August 2005
- Application: ANDA076736
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 October 2008
- Application: ANDA077731
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 September 2009
- Application: ANDA079150
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 26 May 2010
- Application: ANDA077947
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 May 2010
- Application: ANDA077988
- Marketing authorisation holder: WOODWARD
- Local brand name: FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 February 2017
- Application: ANDA208963
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 September 2023
- Application: ANDA215738
- Marketing authorisation holder: ZHEJIANG POLY PHARM
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 January 2026
- Application: ANDA218692
- Marketing authorisation holder: FDC LTD
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
The FDA approved the application number ANDA218692 for Diflucan (Fluconazole) tablets on 8 January 2026. This approval allows FDC LTD to market the product in the United States. Diflucan is indicated for oral administration.
FDA
- Application: ANDA076042
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Diflucan in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Diflucan approved in United States?
Yes. FDA authorised it on 29 July 2004; FDA authorised it on 29 July 2004; FDA authorised it on 29 July 2004.
Who is the marketing authorisation holder for Diflucan in United States?
TARO holds the US marketing authorisation.