Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091379
Company: APOTEX CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SILDENAFIL CITRATE SILDENAFIL CITRATE EQ 20MG BASE 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
11/06/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/091379Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

08/01/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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