Application 203323

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AMIKACIN SULFATE	AMIKACIN SULFATE	INJECTABLE;INJECTION	EQ 250MG BASE/ML	No	No
002	AMIKACIN SULFATE	AMIKACIN SULFATE	INJECTABLE;INJECTION	500MG(BASE)/ML(250MG/ML)	Yes	No
003	AMIKACIN SULFATE	AMIKACIN SULFATE	INJECTABLE;INJECTION	1G(BASE)/4ML(250MG/ML)	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
25021-173	amikacin sulfate	amikacin sulfate	Sagent Pharmaceuticals	ANDA	Current
25021-173	amikacin sulfate	amikacin sulfate	Sagent Pharmaceuticals	ANDA	Current
25021-173	amikacin sulfate	amikacin sulfate	Sagent Pharmaceuticals	ANDA	Current