Phytonadione

Sold as Mephyton, Konakion, Aquamephyton. Every FDA application for this active ingredient: 3 branded and 25 generic.

As of Nov 15, 2026, FDA lists 28 applications for Phytonadione (sold as Mephyton, Konakion, Aquamephyton), first approved Sep 30, 1955, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 30, 1955
Applications: 28
New uses approved: 0
Complete response letters: 0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

PHYTONADIONE 5 MG TABLET: $9.30 per unitGeneric · -5% in a year

Clinical Trials

7 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


The OK Daily StudyInfant Vitamin K Status, Vitamin K Deficiency Bleeding · Norfolk and Norwich University Hospitals NHS Foundation Trust	Not applicable	Not yet recruiting	Jun 2, 2026
Bioavailability of Different Vitamin K Vitamers Studied Using 13C-labelled Vitamin K VitamersBioavailability of Vitamin K · University of Copenhagen	Not applicable	Not yet recruiting	Jun 27, 2025
Vitamin K and Cognition in Coronary Heart Disease (NutriCog)Coronary Heart Disease · Montreal Heart Institute	Not applicable	Not yet recruiting	Mar 4, 2025
The Role of Vitamin K on Knee Osteoarthritis OutcomesOsteo Arthritis Knee · Boston University	Phase 1 / Phase 2	Active, not recruiting	Apr 26, 2024
Effects of Vitamin K on Lower-extremity Function in Adults With Osteoarthritis:Osteo Arthritis Knee · Tufts University	Not applicable	Active, not recruiting	Aug 17, 2022
Better Evidence and Translation for CalciphylaxisCalciphylaxis · University of Sydney	Phase 3	Recruiting	Aug 24, 2021
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)Glioblastoma, Glioblastoma Multiforme · BPGbio	Phase 2	Active, not recruiting	Feb 12, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Sep 30, 1955	MephytonNDA 10104 · New dosage form	Bausch	21	Discontinued
Jun 28, 1960	AquamephytonNDA 12223 · New formulation or manufacturer	Pai Holdings Pharm	27	Discontinued
Mar 1, 1976	PhytonadioneANDA 83722	Intl Medication	16	Marketed
Jul 25, 1983	Vitamin K1ANDA 87954	Hospira	16	Marketed
Jul 25, 1983	Vitamin K1ANDA 87955	Hospira	15	Marketed
Jul 25, 1983	Vitamin K1ANDA 87956	Hospira	2	Discontinued
May 11, 2018	PhytonadioneANDA 209373	Amneal Pharms Co	1	Marketed
Feb 20, 2019	PhytonadioneANDA 210189	Zydus Lifesciences	0	Marketed
May 22, 2019	PhytonadioneANDA 207719	Dr Reddys	0	Marketed
Apr 22, 2022	PhytonadioneANDA 212424	Cipla	0	Discontinued
Apr 22, 2022	PhytonadioneANDA 214596	Cipla	0	Marketed
Jul 28, 2023	PhytonadioneANDA 213329	Sciegen Pharms	0	Marketed
Oct 12, 2023	PhytonadioneANDA 213336	Tp Anda Holdings	0	Marketed
Dec 10, 2024	PhytonadioneANDA 217386	Gland	0	Marketed
Dec 19, 2024	PhytonadioneANDA 212112	Hikma	0	Discontinued
Jan 3, 2025	PhytonadioneANDA 214966	Cipla	0	Marketed
Apr 17, 2025	PhytonadioneANDA 219212	Caplin	0	Marketed
Sep 8, 2025	PhytonadioneANDA 216444	Alembic	0	Marketed
Nov 4, 2025	PhytonadioneANDA 216601	Amneal	0	Marketed
Jan 9, 2026	PhytonadioneANDA 215090	Sunny	0	Marketed
Feb 26, 2026	PhytonadioneANDA 216852	Baxter Hlthcare Corp	0	Marketed
Feb 26, 2026	PhytonadioneANDA 220454	Novax	0	Marketed
Mar 13, 2026	PhytonadioneANDA 216298	Orbicular	0	Marketed
May 15, 2026	PhytonadioneANDA 215820	Dr Reddys	0	Marketed
Jun 1, 2026	PhytonadioneANDA 217734	Amneal	0	Marketed
Sep 30, 2026	PhytonadioneANDA 219175	Lupin	0	Marketed
—	PhytonadioneANDA 84060	Glaxosmithkline	0	Discontinued
—	KonakionNDA 11745	Roche	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA