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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076578
Company: RISING
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
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
10/25/2019 SUPPL-19 Labeling-Medication Guide, 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-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-Medication Guide, Labeling-Package Insert

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-Medication Guide, Labeling-Package Insert

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.

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