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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213592
Company: BRECKENRIDGE

Products on ANDA 213592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213592

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/04/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 213592

ZOLPIDEM TARTRATE

TABLET, EXTENDED RELEASE;ORAL; 6.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMBIEN CR	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021774	COSETTE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213592	BRECKENRIDGE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078970	LUPIN
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090107	SANDOZ
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	6.25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204170	SUN PHARM

TABLET, EXTENDED RELEASE;ORAL; 12.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMBIEN CR	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021774	COSETTE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213592	BRECKENRIDGE
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	078970	LUPIN
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090107	SANDOZ
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	12.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204170	SUN PHARM

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