NDA 20686, held by Bracco. Manganese Chloride Tetrahydrate.
As of Nov 13, 2026, NDA 20686 (Lumenhance), held by Bracco, was first approved by FDA on Dec 19, 1997, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 1997 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lumenhance3.49MG/GM · for solution;oral | Manganese Chloride Tetrahydrate | Discontinued |
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
