Application 012223

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AQUAMEPHYTON	PHYTONADIONE	INJECTABLE;INJECTION	10MG/ML *Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	AQUAMEPHYTON	PHYTONADIONE	INJECTABLE;INJECTION	1MG/0.5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
52565-092	AquaMEPHYTON	phytonadione	Teligent Pharma, Inc.	NDA	Current
52565-093	AquaMEPHYTON	PHYTONADIONE	Teligent Pharma, Inc.	NDA	Current
52565-142	Phytonadione	phytonadione	Teligent Pharma, Inc.	NDA	Current
52565-143	Phytonadione	PHYTONADIONE	Teligent Pharma, Inc.	NDA	Current