NDA 209569, held by Dutch Ophthalmic. Brilliant Blue G.
As of Nov 14, 2026, NDA 209569 (Tissueblue), held by Dutch Ophthalmic, was first approved by FDA on Dec 20, 2019, with 2 approved supplements and 0 published complete response letters.
Indications & Usage TissueBlue 0.025% is indicated to selectively stain the internal limiting membrane (ILM). TissueBlue 0.025% is a disclosing agent
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2019 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tissueblue0.025% · solution;ophthalmic | Brilliant Blue G | RxReference drug |
| Apr 4, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Mar 30, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Dec 20, 2019 | 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
