NDA 50440, held by Lilly. Cephalexin.
As of Nov 13, 2026, NDA 50440 (Keflet), held by Lilly, was first approved by FDA on Oct 12, 1972, with 36 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 17, 1982 | Supplement 43Efficacy (new indication or use) | Approved | None posted |
| Nov 7, 1978 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| Oct 12, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| KefletEQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Cephalexin | DiscontinuedReference drug |
| KefletEQ 1GM BASE · tablet;oral | Cephalexin | Discontinued |
| KefletEQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Cephalexin | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 1991 | Supplement 19Labeling | Approved | None posted |
| Apr 10, 1990 | Supplement 18Labeling | Approved | None posted |
| Jan 27, 1987 | Supplement 9Manufacturing | Approved | None posted |
| Jul 16, 1986 | Supplement 11Labeling | Approved | None posted |
| Nov 22, 1985 | Supplement 8Labeling | Approved | None posted |
| Sep 6, 1985 | Supplement 7Labeling | Approved | None posted |
| Sep 5, 1984 | Supplement 6Manufacturing | Approved | None posted |
| Sep 28, 1983 | Supplement 5Labeling | Approved | None posted |
| Sep 28, 1983 | Supplement 4Labeling | Approved | None posted |
| Aug 15, 1983 | Supplement 3Manufacturing | Approved | None posted |
| Feb 15, 1983 | Supplement 2Manufacturing | Approved | None posted |
| Sep 17, 1982 | Supplement 45Labeling | Approved | None posted |
| Sep 17, 1982 | Supplement 44Labeling | Approved | None posted |
| Sep 17, 1982 | Supplement 43Efficacy (new indication or use) | Approved | None posted |
| Mar 9, 1982 | Supplement 42Manufacturing | Approved | None posted |
| Sep 4, 1981 | Supplement 41Labeling | Approved | None posted |
| Feb 11, 1981 | Supplement 40Manufacturing | Approved | None posted |
| Dec 31, 1980 | Supplement 39Labeling | Approved | None posted |
| May 12, 1980 | Supplement 38Labeling | Approved | None posted |
| Mar 19, 1980 | Supplement 37Manufacturing | Approved | None posted |
| Mar 4, 1980 | Supplement 36Manufacturing | Approved | None posted |
| Nov 21, 1979 | Supplement 35Labeling | Approved | None posted |
| May 21, 1979 | Supplement 34Labeling | Approved | None posted |
| Apr 20, 1979 | Supplement 33Manufacturing | Approved | None posted |
| Jan 13, 1979 | Supplement 31Labeling | Approved | None posted |
| Nov 7, 1978 | Supplement 30Efficacy (new indication or use) | Approved | None posted |
| May 18, 1978 | Supplement 29Manufacturing | Approved | None posted |
| May 25, 1977 | Supplement 28Manufacturing | Approved | None posted |
| Mar 11, 1977 | Supplement 27Manufacturing | Approved | None posted |
| Feb 28, 1977 | Supplement 26Labeling | Approved | None posted |
| Nov 8, 1976 | Supplement 24Manufacturing | Approved | None posted |
| Nov 2, 1976 | Supplement 25Labeling | Approved | None posted |
| Nov 17, 1975 | Supplement 23Labeling | Approved | None posted |
| Oct 20, 1975 | Supplement 22Manufacturing | Approved | None posted |
| Jun 20, 1975 | Supplement 21Labeling | Approved | None posted |
| Dec 27, 1974 | Supplement 20Manufacturing | Approved | None posted |
| Oct 12, 1972 | 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
