NDA 18060, held by Cosette. Acetaminophen.
As of Nov 13, 2026, NDA 18060 (Acephen), held by Cosette, was first approved by FDA on Feb 9, 1978, with 56 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 9, 1978 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acephen120MG · suppository;rectal | Acetaminophen | Discontinued |
| Acephen650MG · suppository;rectal | Acetaminophen | Discontinued |
| Acephen325MG · suppository;rectal | Acetaminophen | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 2, 2014 | Supplement 67Manufacturing · Standard review | Approved | None posted |
| Mar 25, 2014 | Supplement 66Labeling · Standard review | Approved | |
| Nov 1, 2011 | Supplement 65Labeling · Standard review | Approved | |
| Apr 28, 2010 | Supplement 63Labeling · Standard review | Approved | |
| Apr 1, 2010 | Supplement 64Labeling · Standard review | Approved | None posted |
| Feb 15, 2002 | Supplement 59Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1999 | Supplement 58Manufacturing · Standard review | Approved | None posted |
| Mar 31, 1997 | Supplement 55Labeling · Standard review | Approved | |
| Jul 29, 1996 | Supplement 56Manufacturing · Standard review | Approved | None posted |
| Oct 20, 1987 | Supplement 52Labeling | Approved | None posted |
| Aug 26, 1987 | Supplement 53Labeling | Approved | None posted |
| Dec 17, 1986 | Supplement 50Manufacturing · Standard review | Approved | None posted |
| Jan 22, 1985 | Supplement 51Manufacturing · Standard review | Approved | None posted |
| May 11, 1983 | Supplement 49Manufacturing · Standard review | Approved | None posted |
| Apr 22, 1981 | Supplement 48Labeling | Approved | None posted |
| Dec 18, 1980 | Supplement 46Manufacturing · Standard review | Approved | None posted |
| Nov 25, 1980 | Supplement 44Manufacturing · Standard review | Approved | None posted |
| Nov 21, 1980 | Supplement 45Manufacturing · Standard review | Approved | None posted |
| Nov 19, 1980 | Supplement 43Labeling | Approved | None posted |
| Aug 12, 1980 | Supplement 42Labeling | Approved | None posted |
| Mar 6, 1980 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 21, 1980 | Supplement 39Labeling | Approved | None posted |
| Feb 20, 1980 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Feb 13, 1980 | Supplement 38Labeling | Approved | None posted |
| Feb 13, 1980 | Supplement 37Labeling | Approved | None posted |
| Feb 13, 1980 | Supplement 36Labeling | Approved | None posted |
| Nov 6, 1979 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Nov 6, 1979 | Supplement 25Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1979 | Supplement 31Labeling | Approved | None posted |
| Nov 5, 1979 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Oct 24, 1979 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Oct 22, 1979 | Supplement 29Labeling | Approved | None posted |
| Sep 27, 1979 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1979 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Sep 14, 1979 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Sep 12, 1979 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Sep 11, 1979 | Supplement 33Labeling | Approved | None posted |
| Apr 13, 1979 | Supplement 21Labeling | Approved | None posted |
| Mar 15, 1979 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1978 | Supplement 13Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 12Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 7Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 5Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 3Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 2Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 14Labeling | Approved | None posted |
| Oct 6, 1978 | Supplement 15Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 11Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 10Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 9Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 8Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 6Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 4Labeling | Approved | None posted |
| Oct 5, 1978 | Supplement 17Labeling | Approved | None posted |
| Aug 31, 1978 | Supplement 16Labeling | Approved | None posted |
| May 3, 1978 | Supplement 1Labeling | Approved | None posted |
| Feb 9, 1978 | Original applicationNew formulation or manufacturer · 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
