ANDA 216444, held by Alembic. Phytonadione.
As of Nov 15, 2026, ANDA 216444 (Phytonadione), held by Alembic, was first approved by FDA on Sep 8, 2025, 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 8, 2025 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phytonadione1MG/0.5ML · 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
