NDA 22186, held by Long Grove Pharms. Fluorescein Sodium.
As of Nov 13, 2026, NDA 22186 (Ak-Fluor 10%, Ak-Fluor 25%), held by Long Grove Pharms, was first approved by FDA on Aug 8, 2008, with 3 approved supplements and 0 published complete response letters.
AK-FLUOR 10% (100 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Ak-Fluor 10%EQ 500MG BASE/5ML (EQ 100MG BASE/ML) · injectable;intravenous | Fluorescein Sodium | RxReference drug |
| Ak-Fluor 25%EQ 500MG BASE/2ML (EQ 250MG BASE/ML) · injectable;intravenous | Fluorescein Sodium | DiscontinuedReference drug |
| Mar 17, 2026 | Supplement 15Manufacturing | Approved | |
| Feb 28, 2025 | Supplement 13Labeling · Standard review | Approved | |
| Jul 20, 2015 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Aug 8, 2008 | 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
