ANDA 210189, held by Zydus Lifesciences. Phytonadione.
As of Nov 15, 2026, ANDA 210189 (Phytonadione), held by Zydus Lifesciences, was first approved by FDA on Feb 20, 2019, with 0 approved supplements and 0 published complete response letters.
Phytonadione is indicated for the treatment of adults with 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 caused by coumarin or indanedione derivatives; hypoprothrombinemia secondary to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of vitamin K, e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 20, 2019 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phytonadione5MG · tablet;oral | 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
