An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 091169
Company: TEVA

Products on ANDA 091169

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	AB	No	No
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	AB	No	No
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 091169

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/23/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091169s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/07/2019	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/07/2019	SUPPL-7	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/07/2019	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
12/05/2014	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
12/22/2014	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 091169

ESZOPICLONE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	1MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

TABLET;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	2MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

TABLET;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	208451	AUROBINDO PHARMA
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091024	DR REDDYS
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091166	GLENMARK PHARMS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	205504	HETERO LABS LTD V
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	206222	IPCA LABS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091124	LUPIN LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	202929	MACLEODS PHARMS LTD
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091151	MYLAN PHARMS INC
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091113	ORBION PHARMS
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091103	SUN PHARM
ESZOPICLONE	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	No	AB	091169	TEVA
LUNESTA	ESZOPICLONE	3MG	TABLET;ORAL	Prescription	Yes	AB	021476	WAYLIS THERAP

Top