NDA 21664, held by Bausch And Lomb Inc. Bromfenac Sodium.
As of Nov 14, 2026, NDA 21664 (Xibrom, Bromday), held by Bausch And Lomb Inc, was first approved by FDA on Mar 24, 2005, with 6 approved supplements and 0 published complete response letters.
| Oct 16, 2010 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jan 27, 2006 | Supplement 1Efficacy (new indication or use) | Approved | |
| Mar 24, 2005 | Original applicationNew dosage form · Standard review | Approved |
| XibromEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Bromfenac Sodium | DiscontinuedReference drug |
| BromdayEQ 0.09% ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Bromfenac Sodium | DiscontinuedReference drug |
| Dec 11, 2014 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jan 27, 2014 | Supplement 19Labeling · Standard review | Approved | |
| Jan 27, 2014 | Supplement 14Labeling | Approved | |
| Oct 16, 2010 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Jun 2, 2009 | Supplement 10Labeling · Standard review | Approved | |
| Jan 27, 2006 | Supplement 1Efficacy (new indication or use) | Approved | |
| Mar 24, 2005 | Original applicationNew dosage form · Standard review | Approved |
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
