ANDA 212112, held by Hikma. Phytonadione.
As of Nov 15, 2026, ANDA 212112 (Phytonadione), held by Hikma, was first approved by FDA on Dec 19, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phytonadione5MG ยท tablet;oral | Phytonadione | 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
