ANDA 212424, held by Cipla. Phytonadione.
As of Nov 15, 2026, ANDA 212424 (Phytonadione), held by Cipla, was first approved by FDA on Apr 22, 2022, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 22, 2022 | Original application | Approved |
| Phytonadione1MG/0.5ML · injectable;injection | Phytonadione | Discontinued |
| Phytonadione10MG/ML · injectable;injection | Phytonadione | Discontinued |
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
