ANI PHARMS INC Application 076287

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 10MG BASE	No	No
002	FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 20MG BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-1384	Fluoxetine	Fluoxetine Hydrochloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
23812	ORIG	2008-05-30
8887	ORIG	2008-05-28