Application 215654

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML	No	No
002	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 10MG PHOSPHATE/ML	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68083-473	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Gland Pharma Limited	ANDA	Current
68083-474	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Gland Pharma Limited	ANDA	Current