ANDA 74447, held by Bausch And Lomb. Flurbiprofen Sodium.
As of Nov 15, 2026, ANDA 74447 (Flurbiprofen Sodium), held by Bausch And Lomb, was first approved by FDA on Jan 4, 1995, with 14 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flurbiprofen Sodium0.03% · solution/drops;ophthalmic | Flurbiprofen Sodium | Rx |
| Jan 28, 2013 | Supplement 23Labeling · Standard review | Approved | None posted |
| Dec 9, 2002 | Supplement 13Labeling | Approved | None posted |
| Nov 27, 2001 | Supplement 12Manufacturing | Approved | None posted |
| Apr 30, 2001 | Supplement 11Manufacturing | Approved | None posted |
| Mar 7, 2001 | Supplement 10Manufacturing | Approved | None posted |
| Jun 27, 2000 | Supplement 9Manufacturing | Approved | None posted |
| May 18, 2000 | Supplement 7Manufacturing | Approved | None posted |
| Apr 28, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Jun 7, 1999 | Supplement 6Manufacturing | Approved | None posted |
| Nov 19, 1998 | Supplement 4Manufacturing | Approved | None posted |
| Oct 22, 1998 | Supplement 2Manufacturing | Approved | None posted |
| Aug 24, 1998 | Supplement 5Manufacturing | Approved | None posted |
| May 28, 1998 | Supplement 3Manufacturing | Approved | None posted |
| Apr 8, 1997 | Supplement 1Manufacturing | Approved | None posted |
| Jan 4, 1995 | Original application | 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
