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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 084060

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NDA 084060 describes PHYTONADIONE, which is a drug marketed by Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from fifteen 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. Seventeen 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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