Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010997
Company: XANODYNE PHARM

• Medication Guide

Products on NDA 10997

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DARVON	PROPOXYPHENE HYDROCHLORIDE	32MG	CAPSULE;ORAL	Discontinued	None	No	No
DARVON	PROPOXYPHENE HYDROCHLORIDE	65MG	CAPSULE;ORAL	Discontinued	None	No	No

Labels for NDA 010997

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/25/2009	SUPPL-52	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf
09/25/2009	SUPPL-51	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010997s051s052lbl.pdf