ANDA 80689, held by Dell Labs. Cyanocobalamin.
As of Nov 15, 2026, ANDA 80689 (Cyanocobalamin), held by Dell Labs, was first approved by FDA on Jun 22, 1973, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 22, 1973 | Original application | Approved | None posted |
| Cyanocobalamin0.03MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Cyanocobalamin0.1MG/ML · injectable;injection | Cyanocobalamin | Discontinued |
| Cyanocobalamin1MG/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