Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 076578
Company: RISING

• Other Important Information from FDA

Products on ANDA 076578

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 076578

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/2007/076578s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2022	SUPPL-21	Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		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-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
10/25/2019	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/19/2015	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
03/31/2014	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/21/2011	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/19/2008	SUPPL-4	Labeling		Label is not available on this site.