Relieves inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. NDA 12787, held by Eurofarma. Fluocinolone Acetonide.
As of Nov 13, 2026, NDA 12787 (Synalar), held by Eurofarma, was first approved by FDA on Feb 15, 1963, with 39 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Fluocinolone Acetonide Cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 15, 1963 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Synalar0.025% · cream;topical | Fluocinolone Acetonide | RxReference drug |
| Synalar0.01% · cream;topical | Fluocinolone Acetonide | RxReference drug |
| Synalar0.025% · cream;topical | Fluocinolone Acetonide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2013 | Supplement 71Manufacturing · Priority review | Approved | |
| Sep 26, 2000 | Supplement 66Manufacturing · Priority review | Approved | None posted |
| Jul 22, 1996 | Supplement 65Manufacturing · Priority review | Approved | None posted |
| Mar 6, 1995 | Supplement 61Labeling | Approved | None posted |
| Mar 6, 1995 | Supplement 60Labeling | Approved | None posted |
| Mar 1, 1995 | Supplement 64Labeling · Standard review | Approved | None posted |
| Nov 13, 1992 | Supplement 63Manufacturing · Priority review | Approved | None posted |
| Apr 24, 1992 | Supplement 62Manufacturing · Priority review | Approved | None posted |
| Feb 13, 1990 | Supplement 59Manufacturing · Priority review | Approved | None posted |
| Apr 12, 1989 | Supplement 56Manufacturing · Priority review | Approved | None posted |
| Apr 4, 1989 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Feb 10, 1989 | Supplement 57Manufacturing · Priority review | Approved | None posted |
| Dec 20, 1984 | Supplement 55Manufacturing · Priority review | Approved | None posted |
| Aug 29, 1984 | Supplement 54Manufacturing · Priority review | Approved | None posted |
| Sep 7, 1983 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Apr 8, 1983 | Supplement 52Labeling | Approved | None posted |
| Nov 19, 1982 | Supplement 50Manufacturing · Priority review | Approved | None posted |
| Nov 20, 1981 | Supplement 49Manufacturing · Priority review | Approved | None posted |
| Nov 12, 1981 | Supplement 48Manufacturing · Priority review | Approved | None posted |
| Jun 26, 1981 | Supplement 43Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1981 | Supplement 47Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1981 | Supplement 46Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1981 | Supplement 45Manufacturing · Priority review | Approved | None posted |
| Jan 19, 1981 | Supplement 44Manufacturing · Priority review | Approved | None posted |
| Jul 30, 1980 | Supplement 42Manufacturing · Priority review | Approved | None posted |
| Feb 19, 1980 | Supplement 40Labeling | Approved | None posted |
| Feb 19, 1980 | Supplement 39Labeling | Approved | None posted |
| Oct 23, 1979 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Aug 13, 1979 | Supplement 37Manufacturing · Priority review | Approved | None posted |
| Jul 25, 1979 | Supplement 36Manufacturing · Priority review | Approved | None posted |
| Apr 13, 1979 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Jan 10, 1979 | Supplement 31Labeling | Approved | None posted |
| Nov 28, 1978 | Supplement 33Manufacturing · Priority review | Approved | None posted |
| Sep 12, 1978 | Supplement 32Labeling | Approved | None posted |
| Jun 4, 1977 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Jan 4, 1977 | Supplement 29Labeling | Approved | None posted |
| Jul 8, 1976 | Supplement 28Labeling | Approved | None posted |
| Dec 12, 1975 | Supplement 27Labeling | Approved | None posted |
| Jun 26, 1975 | Supplement 26Labeling | Approved | None posted |
| Feb 15, 1963 | Original applicationNew molecular entity · Priority review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
