Phytonadione

ANDA 215820, held by Dr Reddys. Phytonadione.

As of Nov 15, 2026, ANDA 215820 (Phytonadione), held by Dr Reddys, was first approved by FDA on May 15, 2026, with 0 approved supplements and 0 published complete response letters.

First approved: May 15, 2026
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Phytonadione Injectable Emulsion is a vitamin K replacement indicated for the treatment of 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 deficiency caused by coumarin or indanedione derivatives;
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
May 15, 2026	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Phytonadione1MG/0.5ML · injectable;injection	Phytonadione	Rx

Identifiers

Application: ANDA 215820
Drugs@FDA: Overview at FDA
Company: Dr. Reddy's Laboratories

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