LANDELA PHARM Application 075464

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
76365-0101	Fluoxetine	Fluoxetine hydrochloride	Prodigy Health Supplier	ANDA	Current
76365-0102	Fluoxetine	Fluoxetine hydrochloride	Prodigy Health Supplier	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
44257	ORIG	2005-08-01
8678	ORIG	2004-06-04