NDA 21670, held by Dorc. Trypan Blue.
As of Nov 14, 2026, NDA 21670 (Visionblue), held by Dorc, was first approved by FDA on Dec 16, 2004, with 4 approved supplements and 0 published complete response letters.
Indications & Usage VisionBlue 0.06% is indicated for use as an aid in ophthalmic surgery by staining the anterior capsule of the lens. VisionBlue 0.06% is a diagnostic dye
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 2004 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Visionblue0.06% · solution;ophthalmic | Trypan Blue | RxReference drug |
| Dec 18, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Apr 17, 2015 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Aug 25, 2014 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Nov 21, 2012 | Supplement 5Labeling · Standard review | Approved | |
| Dec 16, 2004 | Original applicationNew molecular entity · 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
