ANDA 80855, held by Lilly. Cyanocobalamin.
As of Nov 15, 2026, ANDA 80855 (Betalin 12), held by Lilly, was first approved by FDA on Jul 9, 1973, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 1973 | Original application | Approved | None posted |
| Betalin 120.1MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Betalin 121MG/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
