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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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/09/1971 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/016862_DARVON_N_ORIGINAL_AP.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2009 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
09/25/2009 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/016862s041s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
02/24/1999 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.
10/05/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
08/10/1998 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.
04/02/1998 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/01/2002 SUPPL-33 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10996slr061,%2010997slr043,%2016862slr033ltr.pdf
04/05/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
09/02/1994 SUPPL-31 Labeling

Label is not available on this site.
09/15/1992 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.
08/23/1994 SUPPL-29 Labeling

Label is not available on this site.
04/15/1987 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.
10/16/1986 SUPPL-24 Labeling

Label is not available on this site.
04/18/1986 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.
12/31/1985 SUPPL-21 Labeling

Label is not available on this site.
04/16/1985 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
04/21/1986 SUPPL-18 Labeling

Label is not available on this site.
08/16/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
06/08/1981 SUPPL-15 Labeling

Label is not available on this site.
01/27/1981 SUPPL-13 Labeling

Label is not available on this site.
09/26/1979 SUPPL-12 Labeling

Label is not available on this site.
07/24/1980 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.
01/11/1978 SUPPL-10 Labeling

Label is not available on this site.
10/13/1977 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/13/1977 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.
01/21/1980 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

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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