Is Menadiol sodium diphosphate approved by the US FDA?

Drugs@FDA lists 3 application product lines for Menadiol sodium diphosphate, including SYNKAYVITE (Discontinued); SYNKAYVITE (Discontinued); KAPPADIONE (Discontinued).

Is Menadiol sodium diphosphate authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Menadiol sodium diphosphate, including MENADIOL DIPHOSPHATE 10MG TABLETS.

Active substance

Menadiol sodium diphosphate

US FDA 3
UK MHRA 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
SYNKAYVITE	5MG/ML; 10MG/ML; 37.5MG/ML	injectable · injection	ROCHE	Discontinued	15 Jul 1941
SYNKAYVITE	5MG	tablet · oral	ROCHE	Discontinued	15 Jul 1941
KAPPADIONE	10MG/ML	injectable · injection	LILLY	Discontinued

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
MENADIOL DIPHOSPHATE 10MG TABLETS	PL 16853/0110	ALLIANCE PHARMACEUTICALS LIMITED	P

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.