NDA 216264, held by Provepharm Sas. Indigotindisulfonate Sodium.
As of Nov 13, 2026, NDA 216264 (Bludigo), held by Provepharm Sas, was first approved by FDA on Jul 8, 2022, with 1 approved supplement and 0 published complete response letters.
BLUDIGO is indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults following urological and gynecological open, robotic, or endoscopic surgical procedures.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2022 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bludigo40MG/5ML (8MG/ML) · solution;intravenous | Indigotindisulfonate Sodium | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 14, 2023 | Supplement 1Labeling · Standard review | Approved | |
| Jul 8, 2022 | Original applicationTYPE 7 · 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
