NDA 50182, held by Hospira. Erythromycin Lactobionate.
As of Nov 13, 2026, NDA 50182 (Erythrocin), held by Hospira, was first approved by FDA on Jun 25, 1964, with 118 approved supplements and 0 published complete response letters.
| May 10, 1974 | Supplement 41Efficacy (new indication or use) | Approved | None posted |
| Jun 25, 1964 | Original application | Approved | None posted |
| ErythrocinEQ 500MG BASE/VIAL · injectable;injection | Erythromycin Lactobionate | Discontinued |
| ErythrocinEQ 1GM BASE/VIAL · injectable;injection | Erythromycin Lactobionate | Discontinued |
| Sep 16, 2004 | Supplement 125Labeling · Standard review | Approved | |
| Dec 13, 2002 | Supplement 124Manufacturing | Approved | None posted |
| Aug 29, 2002 | Supplement 123Manufacturing | Approved | None posted |
| May 23, 2002 | Supplement 122Labeling · Standard review | Approved | |
| Apr 23, 1999 | Supplement 121Manufacturing | Approved | None posted |
| Oct 27, 1997 | Supplement 119Manufacturing | Approved | None posted |
| Oct 11, 1996 | Supplement 27Labeling | Approved | None posted |
| Mar 18, 1996 | Supplement 118Manufacturing | Approved | None posted |
| Mar 12, 1993 | Supplement 28Labeling | Approved | None posted |
| Dec 5, 1991 | Supplement 26Manufacturing | Approved | None posted |
| May 3, 1991 | Supplement 23Labeling | Approved | None posted |
| Nov 30, 1988 | Supplement 22Manufacturing | Approved | None posted |
| Dec 30, 1987 | Supplement 21Labeling | Approved | None posted |
| Sep 25, 1984 | Supplement 13Manufacturing | Approved | None posted |
| May 16, 1984 | Supplement 14Manufacturing | Approved | None posted |
| Dec 20, 1983 | Supplement 12Manufacturing | Approved | None posted |
| Nov 9, 1983 | Supplement 11Labeling | Approved | None posted |
| Nov 1, 1983 | Supplement 10Labeling | Approved | None posted |
| Oct 6, 1983 | Supplement 117Manufacturing | Approved | None posted |
| Jul 22, 1983 | Supplement 9Manufacturing | Approved | None posted |
| Jun 2, 1983 | Supplement 8Manufacturing | Approved | None posted |
| May 27, 1983 | Supplement 7Manufacturing | Approved | None posted |
| Oct 8, 1982 | Supplement 2Manufacturing | Approved | None posted |
| Sep 23, 1982 | Supplement 116Manufacturing | Approved | None posted |
| May 21, 1982 | Supplement 115Manufacturing | Approved | None posted |
| Apr 6, 1982 | Supplement 114Manufacturing | Approved | None posted |
| Nov 10, 1981 | Supplement 113Manufacturing | Approved | None posted |
| Oct 7, 1981 | Supplement 112Labeling | Approved | None posted |
| Sep 16, 1981 | Supplement 111Manufacturing | Approved | None posted |
| Jun 5, 1981 | Supplement 110Manufacturing | Approved | None posted |
| May 20, 1981 | Supplement 109Manufacturing | Approved | None posted |
| May 14, 1981 | Supplement 108Manufacturing | Approved | None posted |
| Apr 28, 1981 | Supplement 107Manufacturing | Approved | None posted |
| Mar 3, 1981 | Supplement 106Manufacturing | Approved | None posted |
| Jan 30, 1981 | Supplement 105Labeling | Approved | None posted |
| Dec 17, 1980 | Supplement 104Labeling | Approved | None posted |
| Oct 21, 1980 | Supplement 101Labeling | Approved | None posted |
| Oct 21, 1980 | Supplement 102Labeling | Approved | None posted |
| Sep 23, 1980 | Supplement 100Manufacturing | Approved | None posted |
| Sep 4, 1980 | Supplement 99Manufacturing | Approved | None posted |
| Aug 19, 1980 | Supplement 98Labeling | Approved | None posted |
| Jul 23, 1980 | Supplement 97Labeling | Approved | None posted |
| Jul 17, 1980 | Supplement 96Labeling | Approved | None posted |
| Jul 15, 1980 | Supplement 95Labeling · Standard review | Approved | None posted |
| Jun 26, 1980 | Supplement 94Labeling | Approved | None posted |
| May 23, 1980 | Supplement 93Labeling | Approved | None posted |
| May 22, 1980 | Supplement 91Manufacturing | Approved | None posted |
| May 21, 1980 | Supplement 92Manufacturing | Approved | None posted |
| May 7, 1980 | Supplement 90Manufacturing | Approved | None posted |
| May 7, 1980 | Supplement 87Manufacturing | Approved | None posted |
| May 6, 1980 | Supplement 89Labeling | Approved | None posted |
| May 6, 1980 | Supplement 88Labeling | Approved | None posted |
| Apr 25, 1980 | Supplement 86Manufacturing | Approved | None posted |
| Mar 26, 1980 | Supplement 85Manufacturing | Approved | None posted |
| Mar 25, 1980 | Supplement 84Labeling | Approved | None posted |
| Mar 25, 1980 | Supplement 83Manufacturing | Approved | None posted |
| Mar 17, 1980 | Supplement 82Labeling | Approved | None posted |
| Mar 12, 1980 | Supplement 81Manufacturing | Approved | None posted |
| Feb 15, 1980 | Supplement 80Manufacturing | Approved | None posted |
| Jan 16, 1980 | Supplement 77Manufacturing | Approved | None posted |
| Jan 14, 1980 | Supplement 79Labeling | Approved | None posted |
| Jan 4, 1980 | Supplement 78Manufacturing | Approved | None posted |
| Dec 17, 1979 | Supplement 76Manufacturing | Approved | None posted |
| Nov 23, 1979 | Supplement 75Manufacturing | Approved | None posted |
| Nov 6, 1979 | Supplement 74Labeling | Approved | None posted |
| Nov 6, 1979 | Supplement 73Labeling | Approved | None posted |
| Oct 10, 1979 | Supplement 69Manufacturing | Approved | None posted |
| Sep 18, 1979 | Supplement 72Manufacturing | Approved | None posted |
| Aug 27, 1979 | Supplement 71Manufacturing | Approved | None posted |
| Aug 22, 1979 | Supplement 70Manufacturing | Approved | None posted |
| Jul 19, 1979 | Supplement 64Manufacturing | Approved | None posted |
| Jun 20, 1979 | Supplement 68Manufacturing | Approved | None posted |
| Jun 19, 1979 | Supplement 67Manufacturing | Approved | None posted |
| May 21, 1979 | Supplement 66Manufacturing | Approved | None posted |
| May 4, 1979 | Supplement 65Manufacturing | Approved | None posted |
| Apr 13, 1979 | Supplement 63Manufacturing | Approved | None posted |
| Apr 5, 1979 | Supplement 61Manufacturing | Approved | None posted |
| Mar 29, 1979 | Supplement 59Manufacturing | Approved | None posted |
| Mar 29, 1979 | Supplement 62Manufacturing | Approved | None posted |
| Mar 20, 1979 | Supplement 60Labeling | Approved | None posted |
| Mar 9, 1979 | Supplement 57Manufacturing | Approved | None posted |
| Mar 7, 1979 | Supplement 58Manufacturing | Approved | None posted |
| Jan 19, 1979 | Supplement 56Labeling | Approved | None posted |
| Jan 8, 1979 | Supplement 55Manufacturing | Approved | None posted |
| Dec 13, 1978 | Supplement 54Manufacturing | Approved | None posted |
| Dec 7, 1978 | Supplement 53Manufacturing | Approved | None posted |
| Dec 4, 1978 | Supplement 52Manufacturing | Approved | None posted |
| Oct 30, 1978 | Supplement 50Manufacturing | Approved | None posted |
| Sep 25, 1978 | Supplement 49Labeling | Approved | None posted |
| Jun 7, 1978 | Supplement 48Manufacturing | Approved | None posted |
| May 25, 1978 | Supplement 47Manufacturing | Approved | None posted |
| Aug 9, 1977 | Supplement 46Manufacturing | Approved | None posted |
| Jun 10, 1977 | Supplement 45Manufacturing | Approved | None posted |
| Jan 7, 1975 | Supplement 43Labeling | Approved | None posted |
| May 10, 1974 | Supplement 41Efficacy (new indication or use) | Approved | None posted |
| May 17, 1972 | Supplement 42Labeling | Approved | None posted |
| Nov 19, 1971 | Supplement 40Labeling | Approved | None posted |
| Apr 27, 1971 | Supplement 39Labeling | Approved | None posted |
| Sep 19, 1968 | Supplement 38Labeling | Approved | None posted |
| Jun 15, 1967 | Supplement 37Labeling | Approved | None posted |
| Apr 18, 1967 | Supplement 36Labeling | Approved | None posted |
| Dec 30, 1966 | Supplement 35Manufacturing | Approved | None posted |
| Dec 16, 1966 | Supplement 34Labeling | Approved | None posted |
| May 31, 1966 | Supplement 33Labeling | Approved | None posted |
| Jan 14, 1966 | Supplement 32Labeling | Approved | None posted |
| Oct 8, 1965 | Supplement 31Manufacturing | Approved | None posted |
| Oct 5, 1965 | Supplement 29Manufacturing | Approved | None posted |
| Sep 15, 1965 | Supplement 30Labeling | Approved | None posted |
| May 11, 1965 | Supplement 20Labeling | Approved | None posted |
| May 4, 1965 | Supplement 19Labeling | Approved | None posted |
| Feb 10, 1965 | Supplement 18Labeling | Approved | None posted |
| Oct 27, 1964 | Supplement 16Labeling | Approved | None posted |
| Oct 26, 1964 | Supplement 15Labeling | Approved | None posted |
| Sep 22, 1964 | Supplement 6Labeling | Approved | None posted |
| Aug 20, 1964 | Supplement 5Labeling | Approved | None posted |
| Aug 5, 1964 | Supplement 4Labeling | Approved | None posted |
| Jul 17, 1964 | Supplement 3Labeling | Approved | None posted |
| Jul 13, 1964 | Supplement 1Labeling | Approved | None posted |
| Jun 25, 1964 | 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
