NDA 50461, held by Glaxosmithkline. Cefazolin Sodium.
As of Nov 14, 2026, NDA 50461 (Ancef), held by Glaxosmithkline, was first approved by FDA on Oct 4, 1973, with 89 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 4, 1973 | Original application | Approved | None posted |
| AncefEQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefazolin Sodium | DiscontinuedReference drug |
| AncefEQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefazolin Sodium | DiscontinuedReference drug |
| AncefEQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefazolin Sodium | DiscontinuedReference drug |
| AncefEQ 5GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefazolin Sodium | DiscontinuedReference drug |
| AncefEQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Cefazolin Sodium | DiscontinuedReference drug |
| Jan 6, 2005 | Supplement 138Labeling · Standard review | Approved | |
| Jun 2, 2004 | Supplement 139Labeling · Standard review | Approved | |
| Jan 15, 2004 | Supplement 135Labeling · Standard review | Approved | |
| May 21, 2002 | Supplement 134Manufacturing | Approved | None posted |
| Jul 29, 1999 | Supplement 133Labeling · Standard review | Approved | None posted |
| Jan 4, 1994 | Supplement 132Manufacturing | Approved | None posted |
| Jul 14, 1992 | Supplement 130Labeling | Approved | None posted |
| Jun 22, 1992 | Supplement 50Manufacturing | Approved | None posted |
| May 29, 1992 | Supplement 129Manufacturing | Approved | None posted |
| Mar 12, 1992 | Supplement 45Manufacturing | Approved | None posted |
| Jan 28, 1992 | Supplement 44Manufacturing | Approved | None posted |
| Jun 28, 1991 | Supplement 48Manufacturing | Approved | None posted |
| Feb 14, 1990 | Supplement 43Manufacturing | Approved | None posted |
| Sep 20, 1982 | Supplement 128Labeling | Approved | None posted |
| Jul 12, 1982 | Supplement 126Labeling | Approved | None posted |
| Jul 12, 1982 | Supplement 127Labeling | Approved | None posted |
| Jun 28, 1982 | Supplement 125Labeling | Approved | None posted |
| Jun 4, 1982 | Supplement 124Labeling | Approved | None posted |
| May 18, 1982 | Supplement 123Labeling | Approved | None posted |
| May 12, 1982 | Supplement 122Labeling | Approved | None posted |
| May 5, 1982 | Supplement 121Labeling | Approved | None posted |
| Apr 20, 1982 | Supplement 120Labeling | Approved | None posted |
| Mar 8, 1982 | Supplement 119Labeling | Approved | None posted |
| Feb 19, 1982 | Supplement 118Labeling | Approved | None posted |
| Jan 4, 1982 | Supplement 117Labeling | Approved | None posted |
| Nov 27, 1981 | Supplement 116Manufacturing | Approved | None posted |
| Sep 3, 1981 | Supplement 115Labeling | Approved | None posted |
| Sep 1, 1981 | Supplement 114Labeling | Approved | None posted |
| Aug 11, 1981 | Supplement 113Labeling | Approved | None posted |
| Jul 23, 1981 | Supplement 112Labeling | Approved | None posted |
| Jun 19, 1981 | Supplement 109Labeling | Approved | None posted |
| Jun 10, 1981 | Supplement 111Labeling | Approved | None posted |
| Apr 8, 1981 | Supplement 110Labeling | Approved | None posted |
| Mar 12, 1981 | Supplement 108Labeling | Approved | None posted |
| Feb 11, 1981 | Supplement 107Labeling | Approved | None posted |
| Jan 27, 1981 | Supplement 106Labeling | Approved | None posted |
| Jul 17, 1980 | Supplement 105Labeling | Approved | None posted |
| Mar 5, 1980 | Supplement 104Manufacturing | Approved | None posted |
| Feb 26, 1980 | Supplement 103Labeling | Approved | None posted |
| May 15, 1979 | Supplement 101Manufacturing | Approved | None posted |
| Feb 23, 1979 | Supplement 99Manufacturing | Approved | None posted |
| Nov 28, 1978 | Supplement 98Manufacturing | Approved | None posted |
| Nov 14, 1978 | Supplement 97Labeling | Approved | None posted |
| Oct 18, 1978 | Supplement 96Labeling | Approved | None posted |
| Sep 29, 1978 | Supplement 95Labeling | Approved | None posted |
| Aug 28, 1978 | Supplement 94Labeling | Approved | None posted |
| Aug 22, 1978 | Supplement 93Labeling | Approved | None posted |
| Aug 17, 1978 | Supplement 92Labeling | Approved | None posted |
| Aug 10, 1978 | Supplement 91Labeling | Approved | None posted |
| Jul 25, 1978 | Supplement 90Labeling | Approved | None posted |
| May 23, 1978 | Supplement 88Manufacturing | Approved | None posted |
| May 23, 1978 | Supplement 89Labeling | Approved | None posted |
| May 22, 1978 | Supplement 83Labeling | Approved | None posted |
| Apr 6, 1978 | Supplement 87Manufacturing | Approved | None posted |
| Dec 15, 1977 | Supplement 86Labeling | Approved | None posted |
| Oct 14, 1977 | Supplement 85Labeling | Approved | None posted |
| Jun 9, 1977 | Supplement 84Labeling | Approved | None posted |
| Jun 8, 1977 | Supplement 65Labeling | Approved | None posted |
| Oct 8, 1976 | Supplement 82Labeling | Approved | None posted |
| Aug 12, 1976 | Supplement 81Labeling | Approved | None posted |
| Aug 5, 1976 | Supplement 80Labeling | Approved | None posted |
| Jul 8, 1976 | Supplement 79Manufacturing | Approved | None posted |
| Jun 16, 1976 | Supplement 78Labeling | Approved | None posted |
| Jun 8, 1976 | Supplement 77Labeling | Approved | None posted |
| May 10, 1976 | Supplement 76Manufacturing | Approved | None posted |
| May 6, 1976 | Supplement 75Manufacturing | Approved | None posted |
| Mar 15, 1976 | Supplement 73Manufacturing | Approved | None posted |
| Mar 15, 1976 | Supplement 74Manufacturing | Approved | None posted |
| Mar 1, 1976 | Supplement 72Manufacturing | Approved | None posted |
| Feb 26, 1976 | Supplement 70Labeling | Approved | None posted |
| Feb 26, 1976 | Supplement 71Labeling | Approved | None posted |
| Nov 20, 1975 | Supplement 68Manufacturing | Approved | None posted |
| Nov 20, 1975 | Supplement 69Manufacturing | Approved | None posted |
| Sep 18, 1975 | Supplement 67Manufacturing | Approved | None posted |
| Sep 10, 1975 | Supplement 66Labeling | Approved | None posted |
| Jul 7, 1975 | Supplement 64Labeling | Approved | None posted |
| May 12, 1975 | Supplement 63Labeling | Approved | None posted |
| Apr 29, 1975 | Supplement 62Labeling | Approved | None posted |
| Apr 10, 1975 | Supplement 60Labeling | Approved | None posted |
| Apr 10, 1975 | Supplement 61Labeling | Approved | None posted |
| Feb 25, 1975 | Supplement 59Labeling | Approved | None posted |
| Feb 18, 1975 | Supplement 58Labeling | Approved | None posted |
| Dec 24, 1974 | Supplement 57Labeling | Approved | None posted |
| Oct 3, 1974 | Supplement 53Labeling | Approved | None posted |
| Sep 26, 1974 | Supplement 55Manufacturing | Approved | None posted |
| Sep 26, 1974 | Supplement 56Labeling | Approved | None posted |
| Jun 26, 1974 | Supplement 54Manufacturing | Approved | None posted |
| Mar 15, 1974 | Supplement 52Manufacturing | Approved | None posted |
| Jan 23, 1974 | Supplement 51Labeling | Approved | None posted |
| Oct 4, 1973 | Original application | 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
