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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 213336

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NDA 213336 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Sunny, Agnitio, Amneal Pharms Co, Hikma, Sciegen Pharms, and Zydus Lifesciences, and is included in sixteen NDAs. It is available from twenty-five 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-seven suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 213336

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

Pharmacology for NDA: 213336

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 213336

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	TABLET;ORAL	213336	ANDA	Agnitio Inc.	72134-008	72134-008-01	100 TABLET in 1 BOTTLE (72134-008-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Oct 12, 2023	TE:	AB	RLD:	No

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