NDA 17581, held by Atnahs Pharma US. Naproxen.
As of Nov 13, 2026, NDA 17581 (Naprosyn), held by Atnahs Pharma US, was first approved by FDA on Mar 11, 1976, with 78 approved supplements and 0 published complete response letters.
| Mar 23, 1987 | Supplement 65Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1987 | Supplement 73Efficacy (new indication or use) | Approved | None posted |
| Jul 15, 1980 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Mar 11, 1976 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Nov 21, 2024 | Supplement 117Labeling · Standard review | Approved | |
| May 13, 2024 | Supplement 116Labeling · Standard review | Approved | |
| Apr 28, 2021 | Supplement 115Labeling · Standard review | Approved | |
| Jul 22, 2019 | Supplement 114Labeling · Standard review | Approved | |
| Mar 10, 2017 | Supplement 113Labeling · Standard review | Approved | |
| May 9, 2016 | Supplement 112Labeling · Standard review | Approved | |
| Mar 22, 2013 | Supplement 111Labeling · Standard review | Approved | |
| Jul 25, 2008 | Supplement 110Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 108Labeling · Standard review | Approved | |
| Apr 19, 2007 | Supplement 107Labeling · Standard review | Approved | |
| Mar 10, 2006 | Supplement 105Labeling · Standard review | Approved | |
| Jan 24, 2006 | Supplement 106Labeling · Standard review | Approved | |
| Nov 10, 2004 | Supplement 99Labeling · Standard review | Approved | |
| Nov 10, 2004 | Supplement 100Labeling · Standard review | Approved | |
| Apr 14, 2003 | Supplement 98Labeling · Standard review | Approved | |
| Feb 22, 2002 | Supplement 103Manufacturing · Standard review | Approved | None posted |
| Nov 9, 2001 | Supplement 102Manufacturing · Standard review | Approved | None posted |
| Dec 8, 2000 | Supplement 101Manufacturing · Standard review | Approved | None posted |
| Dec 8, 1994 | Supplement 97Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1994 | Supplement 95Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1994 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Mar 28, 1994 | Supplement 96Manufacturing · Standard review | Approved | None posted |
| Aug 12, 1992 | Supplement 93Manufacturing · Standard review | Approved | None posted |
| May 8, 1992 | Supplement 89Manufacturing · Standard review | Approved | None posted |
| Oct 30, 1991 | Supplement 86Manufacturing · Standard review | Approved | None posted |
| Sep 16, 1991 | Supplement 88Manufacturing · Standard review | Approved | None posted |
| Apr 21, 1989 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Feb 18, 1988 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| Mar 23, 1987 | Supplement 65Efficacy (new indication or use) | Approved | None posted |
| Mar 23, 1987 | Supplement 73Efficacy (new indication or use) | Approved | None posted |
| Dec 16, 1986 | Supplement 63Manufacturing · Standard review | Approved | None posted |
| Dec 16, 1986 | Supplement 72Labeling | Approved | None posted |
| Jul 17, 1986 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Jun 10, 1986 | Supplement 68Manufacturing · Standard review | Approved | None posted |
| Sep 24, 1985 | Supplement 69Labeling | Approved | None posted |
| Apr 29, 1985 | Supplement 60Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1985 | Supplement 53Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1985 | Supplement 62Manufacturing · Standard review | Approved | None posted |
| Apr 23, 1985 | Supplement 64Manufacturing · Standard review | Approved | None posted |
| Sep 9, 1983 | Supplement 54Labeling | Approved | None posted |
| Sep 9, 1983 | Supplement 46Labeling | Approved | None posted |
| Jan 13, 1983 | Supplement 48Manufacturing · Standard review | Approved | None posted |
| Dec 3, 1982 | Supplement 49Labeling | Approved | None posted |
| Dec 3, 1982 | Supplement 50Labeling | Approved | None posted |
| Apr 15, 1982 | Supplement 31Labeling | Approved | None posted |
| Mar 31, 1982 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1982 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Jan 8, 1982 | Supplement 38Manufacturing · Standard review | Approved | None posted |
| Jan 7, 1982 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | Supplement 43Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1981 | Supplement 33Labeling | Approved | None posted |
| Oct 13, 1981 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1981 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1981 | Supplement 40Manufacturing · Standard review | Approved | None posted |
| Oct 13, 1981 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Apr 13, 1981 | Supplement 34Labeling | Approved | None posted |
| Apr 2, 1981 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1980 | Supplement 30Labeling | Approved | None posted |
| Jul 15, 1980 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Jul 15, 1980 | Supplement 4Manufacturing · Standard review | Approved | |
| May 13, 1980 | Supplement 27Labeling | Approved | None posted |
| Apr 14, 1980 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Mar 21, 1980 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| Sep 6, 1979 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jul 17, 1979 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 9, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jul 9, 1979 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Jun 7, 1979 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| May 24, 1979 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 2, 1979 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 2, 1979 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1979 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Feb 15, 1979 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Nov 27, 1978 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| May 2, 1978 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Nov 29, 1976 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| May 13, 1976 | Supplement 2Labeling | Approved | None posted |
| Mar 11, 1976 | Original applicationNew molecular entity · 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
