Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016862
Company: XANODYNE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARVON-N PROPOXYPHENE NAPSYLATE 100MG TABLET;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/25/2009 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf
09/25/2009 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf

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