Application 021860

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
002	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 15MG BASE	Yes	No
003	SARAFEM	FLUOXETINE HYDROCHLORIDE	TABLET;ORAL	EQ 20MG BASE	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0430-0210	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0210	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0215	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current
0430-0220	SARAFEM	fluoxetine hydrochloride	Allergan, Inc.	NDA	Current