NDA 17122, held by Xanodyne Pharm. Acetaminophen; Propoxyphene Napsylate.
As of Nov 13, 2026, NDA 17122 (Darvocet-N 50, Darvocet-N 100), held by Xanodyne Pharm, was first approved by FDA on Dec 19, 1972, with 42 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 19, 1972 | Original applicationNew combination · Standard review | Approved | None posted |
| Darvocet-N 50325MG;50MG · tablet;oral | Acetaminophen; Propoxyphene Napsylate | Discontinued |
| Darvocet-N 100650MG;100MG · tablet;oral | Acetaminophen; Propoxyphene Napsylate | Discontinued |
| Sep 25, 2009 | Supplement 61Labeling · Standard review | Approved | |
| Sep 25, 2009 | Supplement 62Labeling · Standard review | Approved | |
| Jan 24, 2007 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| May 11, 2006 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Jul 13, 2005 | Supplement 57Manufacturing · Standard review | Approved | None posted |
| Apr 12, 2005 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2005 | Supplement 54Manufacturing · Standard review | Approved | None posted |
| Feb 3, 2005 | Supplement 55Manufacturing · Standard review | Approved | None posted |
| Oct 30, 2001 | Supplement 46Labeling · Standard review | Approved | None posted |
| Oct 30, 2001 | Supplement 47Labeling · Standard review | Approved | None posted |
| Feb 24, 1999 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Oct 5, 1998 | Supplement 52Manufacturing · Standard review | Approved | None posted |
| Aug 10, 1998 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Apr 2, 1998 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| May 15, 1997 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Mar 20, 1995 | Supplement 39Labeling · Standard review | Approved | None posted |
| Mar 14, 1995 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Sep 2, 1994 | Supplement 43Labeling · Standard review | Approved | None posted |
| Aug 23, 1994 | Supplement 40Labeling · Standard review | Approved | None posted |
| Apr 5, 1994 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Dec 17, 1993 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1992 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Apr 16, 1987 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Oct 17, 1986 | Supplement 30Labeling · Standard review | Approved | None posted |
| Apr 21, 1986 | Supplement 29Labeling · Standard review | Approved | None posted |
| Apr 3, 1986 | Supplement 28Labeling · Standard review | Approved | None posted |
| Aug 16, 1984 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1984 | Supplement 24Labeling · Standard review | Approved | None posted |
| Oct 28, 1981 | Supplement 23Labeling · Standard review | Approved | None posted |
| May 20, 1981 | Supplement 22Labeling · Standard review | Approved | None posted |
| Apr 16, 1980 | Supplement 21Labeling · Standard review | Approved | None posted |
| Jan 21, 1980 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1979 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 18Labeling · Standard review | Approved | None posted |
| Jun 29, 1979 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1978 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1977 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 6, 1977 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 6, 1977 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Sep 15, 1976 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jun 18, 1974 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Dec 19, 1972 | Original applicationNew combination · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
