NDA 50368, held by Dista. Erythromycin.
As of Nov 13, 2026, NDA 50368 (Ilotycin), held by Dista, was first approved by FDA on Jun 29, 1964, with 41 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 1967 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Jun 29, 1964 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ilotycin0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ยท ointment;ophthalmic | Erythromycin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 14, 1993 | Supplement 10Labeling | Approved | None posted |
| Jul 14, 1993 | Supplement 9Labeling | Approved | None posted |
| Jul 13, 1988 | Supplement 41Manufacturing | Approved | None posted |
| May 22, 1987 | Supplement 8Labeling | Approved | None posted |
| Apr 15, 1986 | Supplement 6Manufacturing | Approved | None posted |
| Mar 10, 1986 | Supplement 5Labeling | Approved | None posted |
| Mar 27, 1985 | Supplement 3Manufacturing | Approved | None posted |
| Mar 6, 1984 | Supplement 2Manufacturing | Approved | None posted |
| Dec 28, 1982 | Supplement 1Manufacturing | Approved | None posted |
| Jun 28, 1982 | Supplement 40Manufacturing | Approved | None posted |
| Dec 23, 1981 | Supplement 39Manufacturing | Approved | None posted |
| Mar 24, 1981 | Supplement 37Labeling | Approved | None posted |
| Feb 11, 1981 | Supplement 38Manufacturing | Approved | None posted |
| Jan 22, 1981 | Supplement 36Labeling | Approved | None posted |
| Oct 21, 1980 | Supplement 35Labeling | Approved | None posted |
| Feb 6, 1980 | Supplement 34Manufacturing | Approved | None posted |
| Jan 31, 1980 | Supplement 33Manufacturing | Approved | None posted |
| Feb 14, 1979 | Supplement 32Manufacturing | Approved | None posted |
| Mar 6, 1978 | Supplement 31Manufacturing | Approved | None posted |
| Jan 21, 1977 | Supplement 30Manufacturing | Approved | None posted |
| Mar 26, 1976 | Supplement 28Labeling | Approved | None posted |
| Mar 26, 1976 | Supplement 29Labeling | Approved | None posted |
| Jan 29, 1976 | Supplement 27Manufacturing | Approved | None posted |
| Sep 9, 1975 | Supplement 26Labeling | Approved | None posted |
| Jan 28, 1975 | Supplement 25Manufacturing | Approved | None posted |
| Jul 23, 1974 | Supplement 24Labeling | Approved | None posted |
| Nov 12, 1973 | Supplement 23Manufacturing | Approved | None posted |
| Feb 16, 1973 | Supplement 22Manufacturing | Approved | None posted |
| Nov 22, 1972 | Supplement 21Manufacturing | Approved | None posted |
| Nov 3, 1972 | Supplement 19Labeling | Approved | None posted |
| Oct 31, 1972 | Supplement 20Labeling | Approved | None posted |
| Dec 1, 1971 | Supplement 18Manufacturing | Approved | None posted |
| Dec 15, 1970 | Supplement 17Manufacturing | Approved | None posted |
| Dec 15, 1969 | Supplement 16Manufacturing | Approved | None posted |
| May 9, 1969 | Supplement 15Labeling | Approved | None posted |
| Apr 28, 1969 | Supplement 14Manufacturing | Approved | None posted |
| Feb 11, 1969 | Supplement 13Manufacturing | Approved | None posted |
| Jan 16, 1969 | Supplement 12Manufacturing | Approved | None posted |
| May 17, 1967 | Supplement 11Labeling | Approved | None posted |
| May 3, 1967 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Jan 14, 1966 | Supplement 4Manufacturing | Approved | None posted |
| Jun 29, 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
