FDA — authorised 29 July 2004
- Application: ANDA076658
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Other parenteral antifungal drugs in United States
FDA authorised Other parenteral antifungal drugs 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: ANDA076077
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076507
- Marketing authorisation holder: TARO
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- 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: 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: ANDA076246
- Marketing authorisation holder: HIKMA
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- 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: 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: ANDA076332
- Marketing authorisation holder: SUN PHARM INDS LTD
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA074681
- Marketing authorisation holder: TEVA
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076351
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076653
- Marketing authorisation holder: DR REDDYS
- Local brand name: FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 2004
- Application: ANDA076665
- Marketing authorisation holder: CHARTWELL
- 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 28 September 2005
- Application: ANDA076957
- Marketing authorisation holder: UNIQUE
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 January 2006
- Application: ANDA077253
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 December 2006
- Application: ANDA076918
- Marketing authorisation holder: TARO PHARM INDS
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 12 September 2007
- Application: ANDA077523
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: FLUCONAZOLE
- Indication: FOR SUSPENSION — ORAL
- 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: ANDA077988
- Marketing authorisation holder: WOODWARD
- Local brand name: FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- 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 7 March 2011
- Application: ANDA078423
- Marketing authorisation holder: ANI PHARMS
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- 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 20 October 2023
- Application: ANDA209146
- Marketing authorisation holder: LUPIN
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 January 2026
- Application: ANDA218692
- Marketing authorisation holder: FDC LTD
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA076386
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA076042
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: FLUCONAZOLE
- Indication: TABLET — ORAL
- Status: approved
Other parenteral antifungal drugs 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 Other parenteral antifungal drugs 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 Other parenteral antifungal drugs in United States?
DR REDDYS LABS INC holds the US marketing authorisation.