NDA 10791, held by Bel Mar. Cyanocobalamin.
As of Nov 14, 2026, NDA 10791 (Rubivite), held by Bel Mar, was first approved by FDA on Jul 14, 1958, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 1958 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Rubivite0.05MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Rubivite0.1MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Rubivite1MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Rubivite0.03MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Rubivite0.12MG/ML · injectable;injection | Cyanocobalamin | 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
