Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077985
Company: DR REDDYS LABS LTD
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/2007/077985s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/20/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

05/04/2009 SUPPL-3 Labeling

Label is not available on this site.

10/07/2008 SUPPL-2 Labeling

Label is not available on this site.

12/31/2007 SUPPL-1 Labeling

Label is not available on this site.

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