ANDA 217734, held by Amneal. Phytonadione.
As of Nov 15, 2026, ANDA 217734 (Phytonadione), held by Amneal, was first approved by FDA on Jun 1, 2026, with 0 approved supplements and 0 published complete response letters.
Phytonadione injectable emulsion is a vitamin K replacement indicated for the treatment of the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. Anticoagulant-induced hypoprothrombinemia deficiency caused by coumarin or indanedione derivatives. Hypoprothrombinemia due to antibacterial therapy. Hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 1, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phytonadione10MG/ML · injectable;injection | Phytonadione | Rx |
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
