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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091113
Company: ORBION PHARMS

Products on ANDA 091113

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 091113

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/10/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2020	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
04/27/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
04/27/2020	SUPPL-3	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091113

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	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	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	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

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