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FDA Orange Book · active-ingredient family

Fluocinolone acetonide

Fluocinolone acetonide is approved as 9 brand and 68 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:YUTIQ · NDA 210331

9

Brand (NDA)

68

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · cream, gel, implant, oil, oil/drops, ointment, shampoo, solution

ProductApplicantApplicationTEApproved
YUTIQRLDALIMERA SCIENCES INCNDA 210331—Oct 12, 2018
ILUVIENRLDALIMERA SCIENCES INCNDA 201923—Sep 26, 2014
DERMOTICRLD×3HILL DERMACNDA 019452ATNov 09, 2005
RETISERTRLDBAUSCH AND LOMBNDA 021737—Apr 08, 2005
CAPEXRLDGALDERMA LABS LPNDA 020001—Aug 27, 1990
SYNALARRLD×3EUROFARMANDA 012787ATApproved Prior to Jan 1, 1982
SYNALARRLDEUROFARMANDA 013960ATApproved Prior to Jan 1, 1982
SYNALARRLDEUROFARMANDA 015296ATApproved Prior to Jan 1, 1982
SYNALAR-HPEUROFARMANDA 016161—Approved Prior to Jan 1, 1982

Generic (ANDA) products (68)

ProductApplicantApplicationTEApproved
FLUOCINOLONE ACETONIDENOVEL LABS INCANDA 207347ATAug 07, 2023
FLUOCINOLONE ACETONIDENOVEL LABS INCANDA 207345ATJul 31, 2023
FLUOCINOLONE ACETONIDEQUAGENANDA 212762ATApr 02, 2021
FLUOCINOLONE ACETONIDEQUAGENANDA 212760ATApr 02, 2021
FLUOCINOLONE ACETONIDEQUAGENANDA 212761ATApr 02, 2021
FLUOCINOLONE ACETONIDETP ANDA HOLDINGSANDA 213264ATFeb 05, 2021
FLUOCINOLONE ACETONIDEENCUBE ETHICALSANDA 209913ATFeb 13, 2019
FLUOCINONIDE ACETONIDEGLENMARK PHARMS LTDANDA 211815—Dec 14, 2018
FLUOCINOLONE ACETONIDECOSETTE PHARMS NCANDA 210747ATNov 05, 2018
FLUOCINONIDE ACETONIDEGLENMARK PHARMS LTDANDA 210539—Oct 26, 2018
FLUOCINOLONE ACETONIDEGLENMARK PHARMS LTDANDA 210556—Oct 25, 2018
FLACANDA REPOSITORYANDA 210736ATApr 11, 2018
FLUOCINOLONE ACETONIDECHARTWELL RXANDA 209596ATDec 26, 2017
FLUOCINOLONE ACETONIDEPADAGIS ISRAELANDA 202849ATJul 17, 2017
FLUOCINOLONE ACETONIDEACTAVIS LABS UT INCANDA 208386—Oct 21, 2016
FLUOCINOLONE ACETONIDECOSETTEANDA 207441—Sep 28, 2016
FLUOCINOLONE ACETONIDESCIEGEN PHARMSANDA 202705—Sep 09, 2016
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 202368ATMay 19, 2016
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 209336ATMay 19, 2016
FLUOCINOLONE ACETONIDERISINGANDA 203378ATApr 25, 2016
FLUOCINOLONE ACETONIDERISINGANDA 090982ATApr 25, 2016
FLUOCINOLONE ACETONIDERISINGANDA 203377ATApr 25, 2016
FLUOCINOLONE ACETONIDELUPINANDA 206422ATSep 02, 2015
FLUOCINOLONE ACETONIDESCIEGEN PHARMSANDA 091514—Jun 25, 2015
FLUOCINOLONE ACETONIDEPADAGIS ISRAELANDA 202847ATAug 09, 2013
FLUOCINOLONE ACETONIDEPADAGIS ISRAELANDA 202848ATAug 09, 2013
FLUOCINOLONE ACETONIDEAMNEALANDA 091306—Oct 17, 2011
FLUOCINOLONE ACETONIDEAMNEALANDA 201759—Oct 17, 2011
FLUOCINOLONE ACETONIDEAMNEALANDA 201764—Oct 17, 2011
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 040035—Oct 31, 1994
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 040042—Oct 31, 1994
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 040041—Sep 15, 1994
FLUOCINOLONE ACETONIDEBAUSCH AND LOMBANDA 040059—Dec 20, 1993
FLUOCINOLONE ACETONIDECOSETTE PHARMS NCANDA 089526ATJul 26, 1988
FLUOCINOLONE ACETONIDECOSETTE PHARMS NCANDA 089525—Jul 26, 1988
FLUOCINOLONE ACETONIDECOSETTE PHARMS NCANDA 089524ATJul 26, 1988
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 089124ATSep 11, 1985
FLUOCINOLONE ACETONIDEUSL PHARMAANDA 088756—Mar 28, 1985
FLUOCINOLONE ACETONIDEUSL PHARMAANDA 088757—Feb 11, 1985
FLUOCINOLONE ACETONIDEUSL PHARMAANDA 088742—Feb 08, 1985
FLUONIDALLERGAN HERBERTANDA 087156—Sep 06, 1984
FLUONIDALLERGAN HERBERTANDA 087157—Sep 06, 1984
FLUOCINOLONE ACETONIDEPHARMAFAIRANDA 088499—Aug 02, 1984
FLUOCINOLONE ACETONIDEPHARMAFAIRANDA 088506—Aug 02, 1984
FLUOCINOLONE ACETONIDEPHARMAFAIRANDA 088507—Feb 27, 1984
FLUOCINOLONE ACETONIDEPHARMAFAIRANDA 088449—Feb 08, 1984
FLUOCINOLONE ACETONIDEPAI HOLDINGS PHARMANDA 088312—Jan 27, 1984
FLUOCETALPHARMA US PHARMSANDA 088360—Jan 16, 1984
FLUOCINOLONE ACETONIDEALPHARMA US PHARMSANDA 088361—Jan 16, 1984
FLUOTREXSAVAGE LABSANDA 088174—May 06, 1983
FLUONIDALLERGAN HERBERTANDA 087158—Mar 17, 1983
FLUOTREXSAVAGE LABSANDA 088173—Mar 09, 1983
FLUOTREXSAVAGE LABSANDA 088172—Mar 09, 1983
FLUOTREXSAVAGE LABSANDA 088171—Mar 09, 1983
FLUOCINOLONE ACETONIDEALLIEDANDA 088047—Dec 16, 1982
FLUOCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 088170ATDec 16, 1982
FLUOCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 088169ATDec 16, 1982
FLUOCINOLONE ACETONIDEINVATECHANDA 088045—Dec 16, 1982
FLUOCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 088168ATDec 16, 1982
FLUOCINOLONE ACETONIDEPHARMADERMANDA 088046—Dec 16, 1982
FLUOCINOLONE ACETONIDEALLIEDANDA 088048—Dec 16, 1982
FLUOCINOLONE ACETONIDEFOUGERA PHARMS INCANDA 088167ATDec 16, 1982
FLUOCINOLONE ACETONIDEALPHARMA US PHARMSANDA 087159—Jun 16, 1982
FLUONIDALLERGAN HERBERTANDA 087300—May 27, 1982
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 087102—Apr 27, 1982
FLUOCINOLONE ACETONIDESUN PHARMA CANADAANDA 087104—Apr 27, 1982
FLUOCINOLONE ACETONIDEPERRIGO NEW YORKANDA 086810—Mar 04, 1982
FLUOCINOLONE ACETONIDEPERRIGO NEW YORKANDA 086811—Mar 04, 1982

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8871241Aug 12, 2027in 1 yr 2 mo
Product
7998108Jan 12, 2028in 1 yr 7 mo
ProductU-3410
9849027Nov 07, 2028in 2 yr 5 mo
ProductU-708

Fluocinolone acetonide — frequently asked questions

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

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