Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078413
Company: AUROBINDO PHARMA

• Other Important Information from FDA

Products on ANDA 078413

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078413

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2007	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
09/02/2022	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-19	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-15	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/19/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
09/19/2019	SUPPL-12	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/19/2015	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
09/11/2013	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
05/09/2011	SUPPL-5	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
08/18/2010	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/23/2009	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078413

ZOLPIDEM TARTRATE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMBIEN	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	Yes	AB	019908	SANOFI AVENTIS US
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	077214	ACME LABS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	077884	APOTEX INC
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	078413	AUROBINDO PHARMA
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	077388	CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	077322	SANDOZ
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	076410	TEVA
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Prescription	No	AB	077903	TORRENT PHARMS

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AMBIEN	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	Yes	AB	019908	SANOFI AVENTIS US
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	077214	ACME LABS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	077884	APOTEX INC
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	078413	AUROBINDO PHARMA
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	077388	CHARTWELL MOLECULAR
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	077322	SANDOZ
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	076410	TEVA
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Prescription	No	AB	077903	TORRENT PHARMS