Application 091124

Type: ANDA
Sponsor: LUPIN LTD

Related Records

Company: LUPIN LTD

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
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-795	Eszopiclone	Eszopiclone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-1748	Eszopiclone	Eszopiclone	A-S Medication Solutions	ANDA	Current
68180-322	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-322	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-323	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-323	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-324	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-324	Eszopiclone	Eszopiclone	Lupin Pharmaceuticals, Inc.	ANDA	Current
70518-2979	Eszopiclone	Eszopiclone	REMEDYREPACK INC.	ANDA	Current
72189-099	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
72189-099	ESZOPICLONE	ESZOPICLONE	DIRECT RX	ANDA	Current
80425-0098	Lunesta	Eszopiclone 1mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0098	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0098	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Lunesta	Eszopiclone 3mg	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current
80425-0115	Eszopiclone	Eszopiclone	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current