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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210189

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NDA 210189 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 210189

Tradename:	PHYTONADIONE
Applicant:	Zydus Lifesciences
Ingredient:	phytonadione
Patents:	0

Pharmacology for NDA: 210189

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 210189

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	TABLET;ORAL	210189	ANDA	Northstar Rx LLC.	16714-973	16714-973-02	1 BOTTLE in 1 CARTON (16714-973-02) / 30 TABLET in 1 BOTTLE
PHYTONADIONE	phytonadione	TABLET;ORAL	210189	ANDA	Coupler LLC	67046-1581	67046-1581-3	30 TABLET in 1 BLISTER PACK (67046-1581-3)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Feb 20, 2019	TE:	AB	RLD:	No

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