ANDA 207719, held by Dr Reddys. Phytonadione.
As of Nov 15, 2026, ANDA 207719 (Phytonadione), held by Dr Reddys, was first approved by FDA on May 22, 2019, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Phytonadione injectable emulsion, USP is indicated in 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. Phytonadione injectable emulsion is indicated in anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 22, 2019 | 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
