ANDA 84629, held by Bel Mar. Hydroxocobalamin.
As of Nov 14, 2026, ANDA 84629 (Hydroxomin), held by Bel Mar, was first approved by FDA on May 1, 1981, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 1, 1981 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Hydroxomin1MG/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
