ANDA 209373, held by Amneal Pharms Co. Phytonadione.
As of Nov 15, 2026, ANDA 209373 (Phytonadione), held by Amneal Pharms Co, was first approved by FDA on May 11, 2018, with 1 approved supplement and 0 published complete response letters.
Phytonadione tablets are 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 absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 2018 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Phytonadione5MG · tablet;oral | Phytonadione | Rx |
| Jul 25, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| May 11, 2018 | Original application | Approved |
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
