NDA 18422, held by Pfizer Pharms. Gemfibrozil.
As of Nov 13, 2026, NDA 18422 (Lopid), held by Pfizer Pharms, was first approved by FDA on Dec 21, 1981, with 43 approved supplements and 0 published complete response letters.
| Jan 17, 1989 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Dec 21, 1981 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Lopid200MG · capsule;oral | Gemfibrozil | Discontinued |
| Lopid300MG · capsule;oral | Gemfibrozil | Discontinued |
| Lopid600MG · tablet;oral | Gemfibrozil | RxReference drug |
| Dec 10, 2020 | Supplement 59Labeling · Standard review | Approved | |
| Apr 25, 2018 | Supplement 58Labeling · Standard review | Approved | |
| Apr 18, 2017 | Supplement 56Labeling · Standard review | Approved | |
| Apr 6, 2016 | Supplement 55Labeling · Standard review | Approved | |
| Nov 5, 2014 | Supplement 54Labeling · Standard review | Approved | |
| Oct 31, 2013 | Supplement 53Labeling · Standard review | Approved | |
| Sep 27, 2010 | Supplement 50Labeling · Standard review | Approved | |
| Jul 14, 2009 | Supplement 48Labeling · Standard review | Approved | |
| Mar 30, 2004 | Supplement 45Labeling · Standard review | Approved | |
| Jan 15, 2003 | Supplement 43Labeling · Standard review | Approved | |
| Sep 26, 2002 | Supplement 42Manufacturing · Standard review | Approved | None posted |
| Aug 7, 2001 | Supplement 41Labeling · Standard review | Approved | |
| Aug 7, 2001 | Supplement 40Labeling · Standard review | Approved | |
| Dec 3, 1998 | Supplement 34Labeling · Standard review | Approved | None posted |
| Jul 18, 1997 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Mar 24, 1995 | Supplement 37Labeling · Standard review | Approved | None posted |
| Mar 24, 1995 | Supplement 35Labeling · Standard review | Approved | None posted |
| Mar 24, 1995 | Supplement 33Labeling · Standard review | Approved | None posted |
| Dec 2, 1992 | Supplement 32Labeling · Standard review | Approved | None posted |
| Mar 16, 1992 | Supplement 31Labeling | Approved | None posted |
| Jun 4, 1990 | Supplement 26Labeling | Approved | None posted |
| Jan 29, 1990 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jan 3, 1990 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 28Manufacturing · Standard review | Approved | None posted |
| May 30, 1989 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jan 17, 1989 | Supplement 22Efficacy (new indication or use) | Approved | None posted |
| Dec 1, 1988 | Supplement 23Manufacturing · Standard review | Approved | None posted |
| Nov 15, 1988 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| May 25, 1988 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1988 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Feb 3, 1988 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Jan 28, 1988 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1987 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Nov 3, 1987 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 26, 1987 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 20, 1986 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Apr 4, 1986 | Supplement 12Labeling | Approved | None posted |
| Dec 20, 1985 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Dec 10, 1985 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Aug 22, 1984 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 26, 1983 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jun 1, 1982 | Supplement 2Labeling | Approved | None posted |
| May 5, 1982 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 21, 1981 | 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
