NDA 21737, held by Bausch And Lomb. Fluocinolone Acetonide.
As of Nov 14, 2026, NDA 21737 (Retisert), held by Bausch And Lomb, was first approved by FDA on Apr 8, 2005, with 7 approved supplements and 0 published complete response letters.
| Aug 5, 2008 | Supplement 10Efficacy (new indication or use) | Approved | |
| Apr 8, 2005 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Retisert0.59MG · implant;intravitreal | Fluocinolone Acetonide | DiscontinuedReference drug |
| Apr 4, 2025 | Supplement 26Labeling · Standard review | Approved | |
| Mar 30, 2015 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| Jun 20, 2014 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| Jun 2, 2011 | Supplement 19Manufacturing | Approved | |
| Nov 30, 2010 | Supplement 18Manufacturing · Priority review | Approved | |
| Aug 5, 2008 | Supplement 10Efficacy (new indication or use) | Approved | |
| Oct 30, 2007 | Supplement 7Labeling · Standard review | Approved | |
| Apr 8, 2005 | Original applicationNew dosage form · Priority 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
