Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077884
Company: APOTEX INC

Products on ANDA 077884

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	5MG	TABLET;ORAL	Discontinued	None	No	No
ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	10MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077884

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2007	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/077884s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/28/2022	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-18	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-17	Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-16	Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
12/13/2014	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/13/2014	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
02/04/2011	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
01/21/2009	SUPPL-9	Labeling		Label is not available on this site.
05/29/2008	SUPPL-5	Labeling		Label is not available on this site.