Last Updated: May 10, 2026

Details for New Drug Application (NDA): 215090

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NDA 215090 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Orbicular, Sunny, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms, Sinotherapeutics Inc, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty-seven suppliers. Additional details are available on the PHYTONADIONE profile page.

The generic ingredient in PHYTONADIONE is phytonadione. There are ten drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 215090

Tradename:	PHYTONADIONE
Applicant:	Sunny
Ingredient:	phytonadione
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jan 9, 2026	TE:	AB1	RLD:	No

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