Application 091169

Type: ANDA
Sponsor: TEVA

Related Records

Company: TEVA

Application Products

Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	1MG	No	No
002	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	2MG	No	No
003	ESZOPICLONE	ESZOPICLONE	TABLET;ORAL	3MG	No	No

NDC Listings For This Application

NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5537	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5538	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5539	Eszopiclone	Eszopiclone	Teva Pharmaceuticals USA, Inc.	ANDA	Current
43353-097	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-101	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-1899	Eszopiclone	Eszopiclone	A-S Medication Solutions	ANDA	Current
50436-5538	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
50436-5539	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
71610-409	Eszopiclone	Eszopiclone	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current

Documents

Document	Submission type	Date
9323	ORIG	2011-05-25