NDA 50504, held by Lilly. Cefamandole Nafate.
As of Nov 13, 2026, NDA 50504 (Mandol), held by Lilly, was first approved by FDA on Sep 27, 1978, with 63 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 1979 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Sep 27, 1978 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| MandolEQ 500MG BASE/VIAL · injectable;injection | Cefamandole Nafate | Discontinued |
| MandolEQ 1GM BASE/VIAL · injectable;injection | Cefamandole Nafate | Discontinued |
| MandolEQ 2GM BASE/VIAL · injectable;injection | Cefamandole Nafate | Discontinued |
| MandolEQ 10GM BASE/VIAL · injectable;injection | Cefamandole Nafate | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 13, 2009 | Supplement 63Labeling · Standard review | Approved | None posted |
| Mar 13, 2009 | Supplement 11Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 15Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 18Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 20Labeling | Approved | None posted |
| Mar 13, 2009 | Supplement 24Labeling | Approved | None posted |
| Mar 4, 2003 | Supplement 62Labeling · Standard review | Approved | |
| Jul 18, 2002 | Supplement 59Labeling · Standard review | Approved | |
| May 22, 2002 | Supplement 64Manufacturing · Priority review | Approved | None posted |
| Jan 5, 1999 | Supplement 61Manufacturing · Priority review | Approved | None posted |
| Jun 18, 1996 | Supplement 60Manufacturing · Priority review | Approved | None posted |
| May 10, 1995 | Supplement 25Labeling | Approved | None posted |
| Jun 18, 1993 | Supplement 28Labeling | Approved | None posted |
| Mar 23, 1993 | Supplement 58Manufacturing · Priority review | Approved | None posted |
| Dec 31, 1992 | Supplement 57Labeling · Standard review | Approved | None posted |
| Oct 14, 1992 | Supplement 29Labeling | Approved | None posted |
| Jun 13, 1991 | Supplement 27Labeling | Approved | None posted |
| Mar 12, 1986 | Supplement 21Labeling | Approved | None posted |
| Mar 12, 1986 | Supplement 22Labeling | Approved | None posted |
| Sep 7, 1984 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Feb 28, 1984 | Supplement 16Manufacturing · Priority review | Approved | None posted |
| Sep 6, 1983 | Supplement 14Labeling | Approved | None posted |
| Aug 24, 1983 | Supplement 13Labeling | Approved | None posted |
| Aug 5, 1983 | Supplement 12Labeling | Approved | None posted |
| Jun 21, 1983 | Supplement 10Labeling | Approved | None posted |
| Jun 20, 1983 | Supplement 9Labeling | Approved | None posted |
| Mar 23, 1983 | Supplement 7Labeling | Approved | None posted |
| Mar 18, 1983 | Supplement 6Labeling | Approved | None posted |
| Feb 17, 1983 | Supplement 5Manufacturing · Priority review | Approved | None posted |
| Feb 1, 1983 | Supplement 4Manufacturing · Priority review | Approved | None posted |
| Dec 14, 1982 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Nov 18, 1982 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Nov 17, 1982 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Sep 3, 1982 | Supplement 26Labeling | Approved | None posted |
| Jul 29, 1982 | Supplement 23Labeling | Approved | None posted |
| Jul 15, 1982 | Supplement 19Labeling | Approved | None posted |
| Nov 19, 1981 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Nov 16, 1981 | Supplement 55Labeling | Approved | None posted |
| Sep 4, 1981 | Supplement 54Labeling | Approved | None posted |
| Feb 11, 1981 | Supplement 53Manufacturing · Priority review | Approved | None posted |
| Nov 23, 1980 | Supplement 52Labeling | Approved | None posted |
| Nov 20, 1980 | Supplement 48Labeling | Approved | None posted |
| Nov 20, 1980 | Supplement 49Labeling | Approved | None posted |
| Nov 20, 1980 | Supplement 50Labeling | Approved | None posted |
| Nov 20, 1980 | Supplement 51Labeling | Approved | None posted |
| Oct 28, 1980 | Supplement 47Labeling | Approved | None posted |
| Oct 3, 1980 | Supplement 46Labeling | Approved | None posted |
| Jul 1, 1980 | Supplement 45Labeling | Approved | None posted |
| Jun 17, 1980 | Supplement 44Labeling | Approved | None posted |
| May 28, 1980 | Supplement 43Labeling | Approved | None posted |
| May 1, 1980 | Supplement 41Manufacturing · Priority review | Approved | None posted |
| May 1, 1980 | Supplement 42Labeling | Approved | None posted |
| Apr 14, 1980 | Supplement 40Labeling | Approved | None posted |
| Nov 13, 1979 | Supplement 39Labeling | Approved | None posted |
| Sep 10, 1979 | Supplement 38Manufacturing · Priority review | Approved | None posted |
| Aug 1, 1979 | Supplement 35Efficacy (new indication or use) | Approved | None posted |
| Aug 1, 1979 | Supplement 37Labeling | Approved | None posted |
| May 15, 1979 | Supplement 36Labeling | Approved | None posted |
| Mar 21, 1979 | Supplement 34Labeling | Approved | None posted |
| Feb 6, 1979 | Supplement 33Labeling | Approved | None posted |
| Jan 15, 1979 | Supplement 32Labeling | Approved | None posted |
| Nov 21, 1978 | Supplement 31Labeling | Approved | None posted |
| Nov 15, 1978 | Supplement 30Manufacturing · Priority review | Approved | None posted |
| Sep 27, 1978 | Original applicationNew molecular entity · Priority 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
