Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077774
Company: AUROBINDO PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STAVUDINE STAVUDINE 1MG/ML FOR SOLUTION;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
12/29/2008 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077774ta-ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/077774s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/31/2012 SUPPL-6 REMS-Modified, Labeling-Package Insert

Label is not available on this site.

12/29/2011 SUPPL-5 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

07/22/2011 SUPPL-4 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/29/2009 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

03/16/2009 SUPPL-1 Labeling

Label is not available on this site.

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