NDA 15296, held by Eurofarma. Fluocinolone Acetonide.
As of Nov 13, 2026, NDA 15296 (Synalar), held by Eurofarma, was first approved by FDA on May 27, 1964, with 37 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 27, 1964 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Synalar0.01% · solution;topical | Fluocinolone Acetonide | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 19, 2012 | Supplement 64Manufacturing · Standard review | Approved | |
| Nov 16, 2012 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Sep 26, 2000 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jul 22, 1996 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Mar 6, 1995 | Supplement 53Labeling | Approved | None posted |
| Mar 2, 1995 | Supplement 56Labeling · Standard review | Approved | None posted |
| Nov 13, 1992 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1992 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1990 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Dec 19, 1989 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Dec 19, 1989 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Feb 10, 1989 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Jul 24, 1985 | Supplement 47Manufacturing · Standard review | Approved | None posted |
| Aug 29, 1984 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Sep 7, 1983 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jun 23, 1983 | Supplement 44Labeling | Approved | None posted |
| Nov 19, 1982 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Nov 16, 1981 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Jun 3, 1981 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Jan 19, 1981 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Feb 19, 1980 | Supplement 34Labeling | Approved | None posted |
| Oct 23, 1979 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Aug 13, 1979 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Mar 14, 1979 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Feb 28, 1979 | Supplement 30Labeling | Approved | None posted |
| Nov 28, 1978 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Jun 30, 1978 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| Jan 9, 1978 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Jun 4, 1977 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| May 11, 1977 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| May 11, 1977 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 12, 1976 | Supplement 21Labeling | Approved | None posted |
| Jan 7, 1976 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| May 27, 1964 | Original applicationNew dosage form · Standard 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
