FDA — authorised 29 July 2004
- Application: ANDA076658
- Marketing authorisation holder: DR REDDYS LABS INC
- Status: approved
🇺🇸 Diflucan in United States
FDA authorised Diflucan on 29 July 2004
Marketing authorisations
FDA — authorised 29 July 2004
- Application: ANDA076303
- Marketing authorisation holder: HOSPIRA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076766
- Marketing authorisation holder: BAXTER HLTHCARE
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 January 2005
- Application: ANDA076837
- Marketing authorisation holder: DR REDDYS
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 March 2005
- Application: ANDA076889
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 July 2008
- Application: ANDA078107
- Marketing authorisation holder: HIKMA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 May 2010
- Application: ANDA077909
- Marketing authorisation holder: WOODWARD
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 2012
- Application: ANDA078698
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 March 2015
- Application: ANDA076665
- Marketing authorisation holder: CHARTWELL
- Indication: Labeling
- Status: approved
FDA — authorised 6 July 2022
- Application: ANDA077253
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 29 January 2025
- Application: ANDA078423
- Marketing authorisation holder: ANI PHARMS
- Indication: Labeling
- Status: approved
The FDA approved Diflucan, an antifungal medication, for marketing in the United States on 29 January 2025. The approval was granted to ANI PHARMS, the marketing authorisation holder. The application was submitted under the standard expedited pathway.
FDA
- Application: ANDA076617
- Marketing authorisation holder: HOSPIRA
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- 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.
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?
DR REDDYS LABS INC holds the US marketing authorisation.