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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212424

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NDA 212424 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in fifteen NDAs. It is available from twenty-four 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-six suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 212424

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Apr 22, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 22, 2022	TE:		RLD:	No

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