Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Sold as Synalar, Synalar-Hp, Derma-Smoothe/Fs, Dermotic, Capex and 3 more. Every FDA application for this active ingredient: 9 branded and 68 generic.
As of Nov 15, 2026, FDA lists 77 applications for Fluocinolone Acetonide (sold as Synalar, Synalar-Hp, Derma-Smoothe/Fs and others), first approved Feb 15, 1963, with 7 new uses approved and 0 published complete response letters.
| Fluocinolone Acetonide | Part D | $11.7M | +0% | 143,707 |
| Iluvien | Part B | $11.3M | +27% | 1,034 |
| Yutiq | Part B | $7.6M | -44% | 694 |
| Iluvien | Part D | $590K | New | 49 |
| Derma-Smoothe-FS | Part D | $18K | -5% | 347 |
| Feb 15, 1963 | SynalarNDA 12787 · New molecular entity | Eurofarma | 39 | Marketed |
| Jun 19, 1963 | SynalarNDA 13960 · New dosage form | Eurofarma | 35 | Marketed |
| May 27, 1964 | SynalarNDA 15296 · New dosage form | Eurofarma | 37 | Marketed |
| Jul 25, 1967 | Synalar-HpNDA 16161 · New formulation or manufacturer | Eurofarma | 26 | Discontinued |
| Apr 27, 1982 | Fluocinolone AcetonideANDA 87102 | Sun Pharma Canada | 16 | Discontinued |
| Apr 27, 1982 | Fluocinolone AcetonideANDA 87104 | Sun Pharma Canada | 13 | Discontinued |
| Jun 16, 1982 | Fluocinolone AcetonideANDA 87159 | Alpharma US Pharms | 0 | Discontinued |
| Dec 16, 1982 | Fluocinolone AcetonideANDA 88045 | Invatech | 0 | Discontinued |
| Dec 16, 1982 | Fluocinolone AcetonideANDA 88167 | Fougera Pharms Inc | 3 | Marketed |
| Dec 16, 1982 | Fluocinolone AcetonideANDA 88168 | Fougera Pharms Inc | 4 | Marketed |
| Dec 16, 1982 | Fluocinolone AcetonideANDA 88169 | Fougera Pharms Inc | 3 | Marketed |
| Dec 16, 1982 | Fluocinolone AcetonideANDA 88170 | Fougera Pharms Inc | 4 | Marketed |
| Mar 9, 1983 | FluotrexANDA 88171 | Savage Labs | 1 | Discontinued |
| Aug 2, 1984 | Fluocinolone AcetonideANDA 88506 | Pharmafair | 0 | Discontinued |
| Aug 2, 1984 | Fluocinolone AcetonideANDA 88499 | Pharmafair | 0 | Discontinued |
| Feb 11, 1985 | Fluocinolone AcetonideANDA 88757 | Usl Pharma | 0 | Discontinued |
| Mar 28, 1985 | Fluocinolone AcetonideANDA 88756 | Usl Pharma | 0 | Discontinued |
| Sep 11, 1985 | Fluocinolone AcetonideANDA 89124 | Sun Pharma Canada | 10 | Marketed |
| Feb 3, 1988 | Derma-Smoothe/Fs, DermoticNDA 19452 · New dosage form | Hill Dermac | 23 | Marketed |
| Jul 26, 1988 | Fluocinolone AcetonideANDA 89524 | Cosette Pharms Nc | 5 | Marketed |
| Jul 26, 1988 | Fluocinolone AcetonideANDA 89525 | Cosette Pharms Nc | 2 | Discontinued |
| Jul 26, 1988 | Fluocinolone AcetonideANDA 89526 | Cosette Pharms Nc | 2 | Marketed |
| Aug 27, 1990 | CapexNDA 20001 · New dosage form | Galderma Labs LP | 12 | Discontinued |
| Dec 20, 1993 | Fluocinolone AcetonideANDA 40059 | Bausch And Lomb | 0 | Discontinued |
| Sep 15, 1994 | Fluocinolone AcetonideANDA 40041 | Sun Pharma Canada | 1 | Discontinued |
| Oct 31, 1994 | Fluocinolone AcetonideANDA 40035 | Sun Pharma Canada | 1 | Discontinued |
| Oct 31, 1994 | Fluocinolone AcetonideANDA 40042 | Sun Pharma Canada | 1 | Discontinued |
| Apr 8, 2005 | RetisertNDA 21737 · New dosage form | Bausch And Lomb | 7 | Discontinued |
| Oct 17, 2011 | Fluocinolone AcetonideANDA 91306 | Amneal | 1 | Discontinued |
| Oct 17, 2011 | Fluocinolone AcetonideANDA 201759 | Amneal | 1 | Discontinued |
| Oct 17, 2011 | Fluocinolone AcetonideANDA 201764 | Amneal | 1 | Discontinued |
| Aug 9, 2013 | Fluocinolone AcetonideANDA 202847 | Padagis Israel | 1 | Marketed |
| Aug 9, 2013 | Fluocinolone AcetonideANDA 202848 | Padagis Israel | 1 | Marketed |
| Sep 26, 2014 | IluvienNDA 201923 · New dosage form | Alimera Sciences Inc | 3 | Marketed |
| Jun 25, 2015 | Fluocinolone AcetonideANDA 91514 | Sciegen Pharms | 0 | Discontinued |
| Sep 2, 2015 | Fluocinolone AcetonideANDA 206422 | Lupin | 0 | Marketed |
| Apr 25, 2016 | Fluocinolone AcetonideANDA 90982 | Rising | 1 | Marketed |
| Apr 25, 2016 | Fluocinolone AcetonideANDA 203377 | Rising | 0 | Marketed |
| Apr 25, 2016 | Fluocinolone AcetonideANDA 203378 | Rising | 2 | Marketed |
| May 19, 2016 | Fluocinolone AcetonideANDA 202368 | Sun Pharma Canada | 0 | Marketed |
| May 19, 2016 | Fluocinolone AcetonideANDA 209336 | Sun Pharma Canada | 1 | Marketed |
| Sep 9, 2016 | Fluocinolone AcetonideANDA 202705 | Sciegen Pharms | 0 | Discontinued |
| Sep 28, 2016 | Fluocinolone AcetonideANDA 207441 | Cosette Pharms Nc | 0 | Discontinued |
| Oct 21, 2016 | Fluocinolone AcetonideANDA 208386 | Actavis Labs Ut Inc | 0 | Discontinued |
| Jul 17, 2017 | Fluocinolone AcetonideANDA 202849 | Padagis Israel | 1 | Marketed |
| Dec 26, 2017 | Fluocinolone AcetonideANDA 209596 | Chartwell Rx | 0 | Marketed |
| Apr 11, 2018 | FlacANDA 210736 | Anda Repository | 0 | Marketed |
| Oct 12, 2018 | YutiqNDA 210331 · New formulation or manufacturer | Alimera Sciences Inc | 0 | Discontinued |
| Oct 25, 2018 | Fluocinolone AcetonideANDA 210556 | Glenmark Pharms Ltd | 1 | Discontinued |
| Oct 26, 2018 | Fluocinonide AcetonideANDA 210539 | Glenmark Pharms Ltd | 1 | Discontinued |
| Nov 5, 2018 | Fluocinolone AcetonideANDA 210747 | Cosette Pharms Nc | 0 | Marketed |
| Dec 14, 2018 | Fluocinonide AcetonideANDA 211815 | Glenmark Pharms Ltd | 1 | Discontinued |
| Feb 13, 2019 | Fluocinolone AcetonideANDA 209913 | Encube Ethicals | 0 | Marketed |
| Feb 5, 2021 | Fluocinolone AcetonideANDA 213264 | Tp Anda Holdings | 0 | Marketed |
| Apr 2, 2021 | Fluocinolone AcetonideANDA 212760 | Quagen | 0 | Marketed |
| Apr 2, 2021 | Fluocinolone AcetonideANDA 212761 | Quagen | 0 | Marketed |
| Apr 2, 2021 | Fluocinolone AcetonideANDA 212762 | Quagen | 0 | Marketed |
| Jul 31, 2023 | Fluocinolone AcetonideANDA 207345 | Novel Labs Inc | 1 | Marketed |
| Aug 7, 2023 | Fluocinolone AcetonideANDA 207347 | Novel Labs Inc | 1 | Marketed |
| — | FluonidANDA 87300 | Allergan Herbert | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 86810 | Perrigo New York | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 86811 | Perrigo New York | 0 | Discontinued |
| — | FluonidANDA 87156 | Allergan Herbert | 0 | Discontinued |
| — | FluonidANDA 87157 | Allergan Herbert | 0 | Discontinued |
| — | FluonidANDA 87158 | Allergan Herbert | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88046 | Pharmaderm | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88047 | Allied | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88048 | Allied | 0 | Discontinued |
| — | FluotrexANDA 88172 | Savage Labs | 1 | Discontinued |
| — | FluotrexANDA 88173 | Savage Labs | 1 | Discontinued |
| — | FluotrexANDA 88174 | Savage Labs | 1 | Discontinued |
| — | Fluocinolone AcetonideANDA 88312 | Pai Holdings Pharm | 0 | Discontinued |
| — | FluocetANDA 88360 | Alpharma US Pharms | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88361 | Alpharma US Pharms | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88507 | Pharmafair | 2 | Discontinued |
| — | Fluocinolone AcetonideANDA 88449 | Pharmafair | 0 | Discontinued |
| — | Fluocinolone AcetonideANDA 88742 | Usl Pharma | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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