ANDA 80778, held by Merck. Hydroxocobalamin.
As of Nov 13, 2026, ANDA 80778 (Alpharedisol), held by Merck, was first approved by FDA on Apr 18, 1975, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 18, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Alpharedisol1MG/ML ยท injectable;injection | Hydroxocobalamin | 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
