Last Updated: June 17, 2026

Details for New Drug Application (NDA): 084060

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NDA 084060 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-eight 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. Thirty suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 084060

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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