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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 216444

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NDA 216444 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 216444

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

Pharmacology for NDA: 216444

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 216444

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	216444	ANDA	Alembic Pharmaceuticals Limited	46708-826	46708-826-05	1 SYRINGE in 1 CARTON (46708-826-05) / .5 mL in 1 SYRINGE
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	216444	ANDA	Alembic Pharmaceuticals Limited	46708-826	46708-826-10	10 SYRINGE in 1 CARTON (46708-826-10) / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Sep 8, 2025	TE:	AB	RLD:	No

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