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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 209373

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NDA 209373 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 209373

Tradename:	PHYTONADIONE
Applicant:	Amneal Pharms Co
Ingredient:	phytonadione
Patents:	0

Pharmacology for NDA: 209373

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 209373

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	TABLET;ORAL	209373	ANDA	Major Pharmaceuticals	0904-6882	0904-6882-10	20 BLISTER PACK in 1 CARTON (0904-6882-10) / 1 TABLET in 1 BLISTER PACK
PHYTONADIONE	phytonadione	TABLET;ORAL	209373	ANDA	AvKARE	42291-566	42291-566-30	1 BOTTLE in 1 BOX (42291-566-30) / 30 TABLET in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	May 11, 2018	TE:	AB	RLD:	No

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