Application 205913

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRASUGREL	PRASUGREL HYDROCHLORIDE	TABLET;ORAL	EQ 5MG BASE	No	No
002	PRASUGREL	PRASUGREL HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4118	Prasugrel	Prasugrel	A-S Medication Solutions	ANDA	Current
50090-4118	Prasugrel	Prasugrel	A-S Medication Solutions	ANDA	Current
65162-001	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-001	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-001	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-001	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-001	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-002	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-002	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-002	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-002	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current
65162-002	Prasugrel	Prasugrel	Amneal Pharmaceuticals LLC	ANDA	Current