NDA 21980, held by Alcon Labs Inc. Fluorescein Sodium.
As of Nov 14, 2026, NDA 21980 (Fluorescite), held by Alcon Labs Inc, was first approved by FDA on Mar 28, 2006, with 5 approved supplements and 0 published complete response letters.
FLUORESCITE Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 28, 2006 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FluoresciteEQ 500MG BASE/5ML (EQ 100MG BASE/ML) · injectable;intravenous | Fluorescein Sodium | RxReference drug |
| Jun 10, 2026 | Supplement 12Labeling · Standard review | Approved | |
| Nov 17, 2021 | Supplement 7Labeling · Standard review | Approved | |
| Feb 2, 2016 | Supplement 4Labeling · Standard review | Approved | |
| Feb 9, 2015 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Feb 12, 2014 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Mar 28, 2006 | Original applicationNew formulation or manufacturer · 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
