Phytonadione

ANDA 219212, held by Caplin. Phytonadione.

As of Nov 15, 2026, ANDA 219212 (Phytonadione), held by Caplin, was first approved by FDA on Apr 17, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Apr 17, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Phytonadione injectable emulsion 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Apr 17, 2025	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phytonadione10MG/ML · injectable;injection	Phytonadione	Rx

Identifiers

Application: ANDA 219212
Drugs@FDA: Overview at FDA
Company: Caplin Steriles

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