Last Updated: September 24, 2026

Details for New Drug Application (NDA): 216852

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NDA 216852 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Orbicular, Sunny, Agnitio, Amneal Pharms Co, Hikma, Novax, Sciegen Pharms, and Zydus Lifesciences, and is included in twenty-one NDAs. It is available from thirty suppliers. Additional details are available on the PHYTONADIONE profile page.

The generic ingredient in PHYTONADIONE is phytonadione. There is one drug master file entry for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 216852

Tradename:	PHYTONADIONE
Applicant:	Baxter Hlthcare Corp
Ingredient:	phytonadione
Patents:	0

Pharmacology for NDA: 216852

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 216852

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	216852	ANDA	Baxter Healthcare Corporation	43066-132	43066-132-10	10 VIAL, SINGLE-DOSE in 1 CARTON (43066-132-10) / .5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Feb 26, 2026	TE:	AB2	RLD:	No

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