Approvals and New Uses
The original application and every efficacy supplement, newest first; all 14 submissions below| Date | Submission | Status | Documents |
|---|
| Dec 27, 1991 | Original application | Approved | None posted |
Products
1 strengths and forms| Product | Active ingredient | Marketing |
|---|
| Fluocinonide0.05% · ointment;topical | Fluocinonide | Rx |
All 14 submissions, including labeling and manufacturing supplements
| Date | Submission | Status | Documents |
|---|
| Oct 26, 2001 | Supplement 14Manufacturing | Approved | None posted |
| Aug 30, 2001 | Supplement 13Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 12Manufacturing | Approved | None posted |
| Dec 23, 1999 | Supplement 11Manufacturing | Approved | None posted |
| Mar 12, 1998 | Supplement 10Manufacturing | Approved | None posted |
| Dec 31, 1996 | Supplement 9Labeling | Approved | None posted |
| Sep 24, 1996 | Supplement 6Manufacturing | Approved | None posted |
| Sep 24, 1996 | Supplement 7Manufacturing | Approved | None posted |
| Jun 13, 1996 | Supplement 8Manufacturing | Approved | None posted |
| Dec 14, 1994 | Supplement 5Manufacturing | Approved | None posted |
| Nov 23, 1993 | Supplement 3Manufacturing | Approved | None posted |
| Nov 24, 1992 | Supplement 2Manufacturing | Approved | None posted |
| May 8, 1992 | Supplement 1Manufacturing | Approved | None posted |
| Dec 27, 1991 | Original application | Approved | None posted |
Identifiers
- Application
- ANDA 73481
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
