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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079007
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ANASTROZOLE ANASTROZOLE 1MG 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
06/28/2010 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079007s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/13/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/13/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

11/28/2011 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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