NDA 7012, held by Bayer Hlthcare. Cyanocobalamin.
As of Nov 13, 2026, NDA 7012 (Vi-Twel), held by Bayer Hlthcare, was first approved by FDA on Sep 15, 1949, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 15, 1949 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Vi-Twel1MG/ML ยท 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
