NDA 21092, held by Metabolic Solutions. Urea C-13.
As of Nov 14, 2026, NDA 21092 (Helicosol), held by Metabolic Solutions, was first approved by FDA on Dec 17, 1999, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 17, 1999 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Helicosol125MG/VIAL · for solution;oral | Urea C-13 | Discontinued |
| Oct 20, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 17, 1999 | Original applicationNew formulation or manufacturer · 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
