Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 077903
Company: TORRENT PHARMS

• Other Important Information from FDA

Products on ANDA 077903

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 077903

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2007	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
09/12/2022	SUPPL-30	Labeling-Package Insert		Label is not available on this site.
11/29/2019	SUPPL-29	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/29/2019	SUPPL-28	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/29/2019	SUPPL-27	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
11/29/2019	SUPPL-25	Labeling-Patient Package Insert, Labeling-Package Insert		Label is not available on this site.
11/29/2019	SUPPL-24	Labeling-Package Insert		Label is not available on this site.
11/29/2019	SUPPL-23	Labeling-Package Insert		Label is not available on this site.
12/24/2014	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/24/2014	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/16/2010	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
03/10/2010	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/10/2010	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
03/10/2010	SUPPL-6	Labeling-Container/Carton Labels		Label is not available on this site.
01/08/2010	SUPPL-4	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077903

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