Application 091166

Type: ANDA
Sponsor: GLENMARK GENERICS

Related Records

Company: GLENMARK GENERICS

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
50090-3989	Eszopiclone	Eszopiclone	A-S Medication Solutions	ANDA	Current
50436-3383	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
50436-3384	Eszopiclone	Eszopiclone	Unit Dose Services	ANDA	Current
53217-150	Eszopiclone	Eszopiclone	Aidarex Pharmaceuticals LLC	ANDA	Current
60760-526	Eszopiclone	Eszopiclone	St Mary's Medical Park Phcy	ANDA	Current
61919-991	ESZOPICLONE	ESZOPICLONE	DirectRX	ANDA	Current
61919-991	ESZOPICLONE	ESZOPICLONE	DirectRX	ANDA	Current
61919-991	ESZOPICLONE	ESZOPICLONE	DirectRX	ANDA	Current
61919-991	ESZOPICLONE	ESZOPICLONE	DirectRX	ANDA	Current
68071-2403	Eszopiclone	Eszopiclone	NuCare Pharmaceuticals,Inc.	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-382	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals	ANDA	Current
68462-383	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68462-384	Eszopiclone	Eszopiclone	Glenmark Pharmaceuticals Inc. USA	ANDA	Current
68788-8077	Eszopiclone	Eszopiclone	Preferred Pharmaceuticals Inc. USA	ANDA	Current
68788-8077	Eszopiclone	Eszopiclone	Preferred Pharmaceuticals Inc. USA	ANDA	Current
68788-8923	Eszopiclone	Eszopiclone	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9318	Eszopiclone	Eszopiclone	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9318	Eszopiclone	Eszopiclone	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0888	Eszopiclone	Eszopiclone	REMEDYREPACK INC.	ANDA	Current
70518-0888	Eszopiclone	Eszopiclone	REMEDYREPACK INC.	ANDA	Current
71205-581	Eszopiclone	Eszopiclone	Proficient Rx LP	ANDA	Current
71205-581	Eszopiclone	Eszopiclone	Proficient Rx LP	ANDA	Current
71205-633	Eszopiclone	Eszopiclone	Proficient Rx LP	ANDA	Current
71205-633	Eszopiclone	Eszopiclone	Proficient Rx LP	ANDA	Current
71205-633	Eszopiclone	Eszopiclone	Proficient Rx LP	ANDA	Current
71335-0512	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0512	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0512	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0512	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-0574	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current
71335-2002	Eszopiclone	Eszopiclone	Bryant Ranch Prepack	ANDA	Current