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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 207719

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NDA 207719 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 207719

Tradename:	PHYTONADIONE
Applicant:	Dr Reddys
Ingredient:	phytonadione
Patents:	0

Pharmacology for NDA: 207719

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 207719

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	207719	ANDA	Henry Schein, Inc.	0404-9969	0404-9969-01	1 AMPULE in 1 BAG (0404-9969-01) / 1 mL in 1 AMPULE
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	207719	ANDA	Dr.Reddy's Laboratories Inc	43598-405	43598-405-16	25 AMPULE in 1 CARTON (43598-405-16) / 1 mL in 1 AMPULE (43598-405-11)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	May 22, 2019	TE:	AB1	RLD:	No

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