NDA 19525, held by Allergan. Fluorometholone; Sulfacetamide Sodium.
As of Nov 13, 2026, NDA 19525 (Fml-S), held by Allergan, was first approved by FDA on Sep 29, 1989, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 29, 1989 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Fml-S0.1%;10% · suspension/drops;ophthalmic | Fluorometholone; Sulfacetamide Sodium | Discontinued |
| Mar 10, 2005 | Supplement 10Manufacturing · Standard review | Approved | |
| Apr 12, 2002 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 4, 2001 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2001 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Oct 2, 2000 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| May 1, 1998 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jan 9, 1998 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Sep 30, 1997 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1996 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Aug 3, 1995 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1990 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jul 9, 1990 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 29, 1989 | Original applicationNew combination · 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
