Last Updated: November 8, 2026

Details for New Drug Application (NDA): 217734

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NDA 217734 describes PHYTONADIONE, which is a drug marketed by Alembic, Amneal, Baxter Hlthcare Corp, Caplin, Cipla, Dr Reddys, Gland, Glaxosmithkline, Intl Medication, Lupin, Orbicular, Sunny, Amneal Pharms Co, Hikma, Novax, Sciegen Pharms, Tp Anda Holdings, and Zydus Lifesciences, and is included in twenty-two NDAs. It is available from thirty-two 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-three suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 217734

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

Pharmacology for NDA: 217734

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 217734

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	217734	ANDA	Amneal Pharmaceuticals Private Limited	80830-1683	80830-1683-3	5 TRAY in 1 CARTON (80830-1683-3) / 5 VIAL, GLASS in 1 TRAY (80830-1683-2) / 1 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Jun 1, 2026	TE:	AB1	RLD:	No

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