Details for New Drug Application (NDA): 216298

NDA 216298 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, Sciegen Pharms, Sinotherapeutics Inc, and Zydus Lifesciences, and is included in nineteen NDAs. It is available from twenty-eight 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. Thirty suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 216298

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

Pharmacology for NDA: 216298

Physiological Effect

Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 216298

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	216298	ANDA	Sun Pharmaceutical Industries, Inc.	70095-154	70095-154-02	10 CARTON in 1 CARTON (70095-154-02) / 1 BLISTER PACK in 1 CARTON (70095-154-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	216298	ANDA	Orbicular Pharmaceutical Technologies Private Limited	81607-020	81607-020-02	10 CARTON in 1 CARTON (81607-020-02) / 1 BLISTER PACK in 1 CARTON (81607-020-01) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Mar 13, 2026	TE:	AB1	RLD:	No

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