Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201509
Company: ENDO OPERATIONS

Products on ANDA 201509

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	AB	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201509

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/2016	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/15/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
11/15/2019	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201509

ZOLPIDEM TARTRATE

TABLET;SUBLINGUAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDLUAR	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	Yes	AB	021997	MYLAN SPECIALITY LP
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	ENDO OPERATIONS

TABLET;SUBLINGUAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EDLUAR	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	Yes	AB	021997	MYLAN SPECIALITY LP
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;SUBLINGUAL	Prescription	No	AB	201509	ENDO OPERATIONS