FDA — authorised 30 June 1971
- Status: approved
🇺🇸 Lidex in United States
FDA authorised Lidex on 30 June 1971
Marketing authorisations
FDA — authorised 30 June 1971
- Application: NDA016908
- Marketing authorisation holder: ALVOGEN
- Local brand name: LIDEX-E
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 22 September 1971
- Application: NDA016909
- Marketing authorisation holder: ALVOGEN
- Local brand name: LIDEX
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 15 May 1973
- Application: NDA017373
- Marketing authorisation holder: ALVOGEN
- Local brand name: FLUOCINONIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 6 April 1984
- Application: NDA018849
- Marketing authorisation holder: ALVOGEN
- Local brand name: LIDEX
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 10 June 1987
- Application: ANDA071500
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 2 December 1988
- Application: ANDA071535
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 19 January 1989
- Application: ANDA072494
- Marketing authorisation holder: TARO
- Local brand name: FLUOCINONIDE EMULSIFIED BASE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 6 February 1989
- Application: ANDA072488
- Marketing authorisation holder: TEVA
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 February 1989
- Application: ANDA072537
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINONIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 7 February 1989
- Application: ANDA072490
- Marketing authorisation holder: TEVA
- Local brand name: FLUOCINONIDE EMULSIFIED BASE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 7 February 1989
- Application: ANDA072511
- Marketing authorisation holder: TEVA
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 2 August 1989
- Application: ANDA072857
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 28 September 1990
- Application: ANDA072522
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 27 December 1991
- Application: ANDA073481
- Marketing authorisation holder: TEVA
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 14 February 1992
- Application: ANDA073085
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 17 October 1994
- Application: ANDA073030
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 30 December 1994
- Application: ANDA072933
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: FLUOCINONIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 27 February 1995
- Application: ANDA072934
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 13 June 1995
- Application: ANDA074204
- Marketing authorisation holder: COSETTE
- Local brand name: FLUOCINONIDE EMULSIFIED BASE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 July 1997
- Application: ANDA074935
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINONIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 26 August 1997
- Application: ANDA074905
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 30 June 1999
- Application: ANDA075008
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 June 2004
- Application: ANDA076586
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: FLUOCINONIDE EMULSIFIED BASE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 January 2014
- Application: ANDA090256
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 July 2014
- Application: ANDA200735
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 July 2014
- Application: ANDA200734
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 14 July 2014
- Application: ANDA091282
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 8 January 2016
- Application: ANDA074799
- Marketing authorisation holder: SUN PHARMA CANADA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 21 July 2017
- Application: ANDA206003
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA207538
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 23 April 2018
- Application: ANDA209283
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 23 April 2018
- Application: ANDA209118
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 4 June 2018
- Application: ANDA211111
- Marketing authorisation holder: AMNEAL
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 19 June 2018
- Application: ANDA209030
- Marketing authorisation holder: PADAGIS US
- Local brand name: FLUOCINONIDE
- Indication: GEL — TOPICAL
- Status: approved
FDA — authorised 17 July 2018
- Application: ANDA208948
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 21 August 2018
- Application: ANDA210554
- Marketing authorisation holder: AMNEAL
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 28 September 2018
- Application: ANDA207680
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 16 October 2018
- Application: ANDA211410
- Marketing authorisation holder: ENCUBE
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 29 November 2018
- Application: ANDA209699
- Marketing authorisation holder: ENCUBE ETHICALS
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 18 March 2019
- Application: ANDA207554
- Marketing authorisation holder: SCIEGEN PHARMS
- Local brand name: FLUOCINONIDE
- Indication: SOLUTION — TOPICAL
- Status: approved
FDA — authorised 3 April 2019
- Application: ANDA211758
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 26 November 2019
- Application: ANDA212976
- Marketing authorisation holder: XIROMED
- Local brand name: FLUOCINONIDE
- Indication: OINTMENT — TOPICAL
- Status: approved
FDA — authorised 10 February 2020
- Application: ANDA208989
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
FDA
- Application: ANDA071790
- Marketing authorisation holder: PERRIGO NEW YORK
- Local brand name: FLUOCINONIDE
- Indication: CREAM — TOPICAL
- Status: approved
Lidex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Lidex approved in United States?
Yes. FDA authorised it on 30 June 1971; FDA authorised it on 30 June 1971; FDA authorised it on 22 September 1971.
Who is the marketing authorisation holder for Lidex in United States?
Marketing authorisation holder not available in our data.