Last Updated: November 8, 2026

Details for New Drug Application (NDA): 215820

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NDA 215820 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 215820

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

Pharmacology for NDA: 215820

Physiological Effect	Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 215820

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	215820	ANDA	Dr.Reddys Laboratories Inc	43598-032	43598-032-37	10 CARTON in 1 BOX (43598-032-37) / 1 SYRINGE, GLASS in 1 CARTON (43598-032-11) / .5 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	May 15, 2026	TE:	AB1	RLD:	No

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