Details for New Drug Application (NDA): 214596

NDA 214596 describes PHYTONADIONE, which is a drug marketed by Cipla, Dr Reddys, Glaxosmithkline, Intl Medication, Agnitio, Amneal Pharms Co, Sciegen Pharms Inc, and Zydus Lifesciences, and is included in nine NDAs. It is available from fifteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the phytonadione profile page.

Summary for 214596

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

Pharmacology for NDA: 214596

Physiological Effect

Increased Prothrombin Activity Reversed Anticoagulation Activity

Suppliers and Packaging for NDA: 214596

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214596	ANDA	Cipla USA Inc.	69097-708	69097-708-96	10 VIAL in 1 CARTON (69097-708-96) / 1 mL in 1 VIAL
PHYTONADIONE	phytonadione	INJECTABLE;INJECTION	214596	ANDA	Cipla USA Inc.	69097-709	69097-709-96	10 VIAL in 1 CARTON (69097-709-96) / .5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1MG/0.5ML
Approval Date:	Apr 22, 2022	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	10MG/ML
Approval Date:	Apr 22, 2022	TE:		RLD:	No

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