Application 209830

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARISTADA INITIO KIT	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	675MG/2.4ML	Yes	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current