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FDA Orange Book · active-ingredient family

Fluocinonide

Fluocinonide is approved as 6 brand and 41 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VANOS · NDA 021758

6

Brand (NDA)

41

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, gel, ointment, solution

ProductApplicantApplicationTEApproved
VANOSRLDBAUSCHNDA 021758ABFeb 11, 2005
FLUOCINONIDERLDSUN PHARMA CANADANDA 019117—Jun 26, 1984
LIDEXRLDALVOGENNDA 018849—Apr 06, 1984
LIDEXRLD×2ALVOGENNDA 016908—Approved Prior to Jan 1, 1982
FLUOCINONIDERLDALVOGENNDA 017373—Approved Prior to Jan 1, 1982
LIDEXRLDALVOGENNDA 016909—Approved Prior to Jan 1, 1982

Generic (ANDA) products (41)

ProductApplicantApplicationTEApproved
FLUOCINONIDEQUAGENANDA 216389ATFeb 26, 2025
FLUOCINONIDEZYDUS LIFESCIENCESANDA 208989ABFeb 10, 2020
FLUOCINONIDEXIROMEDANDA 212976ABNov 26, 2019
FLUOCINONIDEENCUBEANDA 211758—Apr 03, 2019
FLUOCINONIDESCIEGEN PHARMSANDA 207554ATMar 18, 2019
FLUOCINONIDEENCUBE ETHICALSANDA 209699ATNov 29, 2018
FLUOCINONIDEENCUBEANDA 211410AB1Oct 16, 2018
FLUOCINONIDEPAI HOLDINGS PHARMANDA 207680—Sep 28, 2018
FLUOCINONIDEAMNEALANDA 210554AB1Aug 21, 2018
FLUOCINONIDEZYDUS PHARMSANDA 208948ATJul 17, 2018
FLUOCINONIDEPADAGIS USANDA 209030ABJun 19, 2018
FLUOCINONIDEAMNEALANDA 211111—Jun 04, 2018
FLUOCINONIDECHARTWELL RXANDA 209118ATApr 23, 2018
FLUOCINONIDEMACLEODS PHARMS LTDANDA 209283ATApr 23, 2018
FLUOCINONIDECHARTWELL RXANDA 207538ABJul 31, 2017
FLUOCINONIDENOVEL LABS INCANDA 206003ATJul 21, 2017
FLUOCINONIDEFOUGERA PHARMS INCANDA 200735ABJul 14, 2014
FLUOCINONIDEGLENMARK PHARMS LTDANDA 091282—Jul 14, 2014
FLUOCINONIDESUN PHARMA CANADAANDA 200734ABJul 14, 2014
FLUOCINONIDEPADAGIS ISRAELANDA 090256—Jan 14, 2014
FLUOCINONIDE EMULSIFIED BASEFOUGERA PHARMSANDA 076586AB2Jun 23, 2004
FLUOCINONIDESUN PHARMA CANADAANDA 075008ABJun 30, 1999
FLUOCINONIDEFOUGERA PHARMSANDA 074905ABAug 26, 1997
FLUOCINONIDESUN PHARMA CANADAANDA 074935ABJul 29, 1997
FLUOCINONIDESUN PHARMA CANADAANDA 074799ATDec 31, 1996
FLUOCINONIDE EMULSIFIED BASECOSETTE PHARMS NCANDA 074204AB2Jun 13, 1995
FLUOCINONIDEFOUGERA PHARMS INCANDA 072934ATFeb 27, 1995
FLUOCINONIDEFOUGERA PHARMS INCANDA 072933ABDec 30, 1994
FLUOCINONIDEFOUGERA PHARMS INCANDA 073030AB1Oct 17, 1994
FLUOCINONIDECOSETTE PHARMS NCANDA 073085AB1Feb 14, 1992
FLUOCINONIDETEVAANDA 073481ABDec 27, 1991
FLUOCINONIDETEVA PHARMSANDA 072522—Sep 28, 1990
FLUOCINONIDESUN PHARMA CANADAANDA 072857—Aug 02, 1989
FLUOCINONIDE EMULSIFIED BASETEVAANDA 072490AB2Feb 07, 1989
FLUOCINONIDECOSETTEANDA 072537—Feb 07, 1989
FLUOCINONIDETEVAANDA 072511—Feb 07, 1989
FLUOCINONIDETEVAANDA 072488AB1Feb 06, 1989
FLUOCINONIDE EMULSIFIED BASETAROANDA 072494AB2Jan 19, 1989
FLUOCINONIDECOSETTEANDA 071535—Dec 02, 1988
FLUOCINONIDEPERRIGO NEW YORKANDA 071790—Jul 13, 1988
FLUOCINONIDESUN PHARMA CANADAANDA 071500AB1Jun 10, 1987

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.

Fluocinonide — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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