Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017122
Company: XANODYNE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DARVOCET-N 100 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 650MG;100MG TABLET;ORAL Discontinued None No No
DARVOCET-N 50 ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE 325MG;50MG 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
12/19/1972 ORIG-1 Approval Type 4 - New Combination STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/25/2009 SUPPL-62 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
09/25/2009 SUPPL-61 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010997s051,052,016862s041,042,017122s061,062ltr.pdf
01/24/2007 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

05/11/2006 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

07/13/2005 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

04/12/2005 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

02/03/2005 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

02/03/2005 SUPPL-54 Manufacturing (CMC)

Label is not available on this site.

02/24/1999 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

10/05/1998 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

08/10/1998 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

04/02/1998 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/15/1997 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/2001 SUPPL-47 Labeling

Label is not available on this site.

10/30/2001 SUPPL-46 Labeling

Label is not available on this site.

03/14/1995 SUPPL-45 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/05/1994 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

09/02/1994 SUPPL-43 Labeling

Label is not available on this site.

09/15/1992 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/17/1993 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

08/23/1994 SUPPL-40 Labeling

Label is not available on this site.

03/20/1995 SUPPL-39 Labeling

Label is not available on this site.

04/16/1987 SUPPL-34 Manufacturing (CMC)-Control

Label is not available on this site.

10/17/1986 SUPPL-30 Labeling

Label is not available on this site.

04/21/1986 SUPPL-29 Labeling

Label is not available on this site.

04/03/1986 SUPPL-28 Labeling

Label is not available on this site.

08/16/1984 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

08/07/1984 SUPPL-24 Labeling

Label is not available on this site.

10/28/1981 SUPPL-23 Labeling

Label is not available on this site.

05/20/1981 SUPPL-22 Labeling

Label is not available on this site.

04/16/1980 SUPPL-21 Labeling

Label is not available on this site.

09/26/1979 SUPPL-20 Labeling

Label is not available on this site.

11/06/1979 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

07/17/1979 SUPPL-18 Labeling

Label is not available on this site.

06/29/1979 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/16/1978 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/21/1980 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1977 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/06/1977 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/1977 SUPPL-11 Labeling

Label is not available on this site.

09/15/1976 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/18/1974 SUPPL-5 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-62 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf
09/25/2009 SUPPL-61 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017122s061s062lbl.pdf

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