ANDA 62768, held by Teva. Cephalexin.
As of Nov 13, 2026, ANDA 62768 (Cephalexin), held by Teva, was first approved by FDA on Jun 16, 1987, with 17 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 1987 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| CephalexinEQ 250MG BASE/5ML ยท for suspension;oral | Cephalexin | Discontinued |
| Sep 11, 2000 | Supplement 21Manufacturing | Approved | None posted |
| Jul 15, 1998 | Supplement 19Manufacturing | Approved | None posted |
| Jul 15, 1998 | Supplement 18Labeling | Approved | None posted |
| Aug 20, 1997 | Supplement 17Manufacturing | Approved | None posted |
| Jul 16, 1996 | Supplement 16Labeling | Approved | None posted |
| Jul 3, 1996 | Supplement 15Manufacturing | Approved | None posted |
| May 4, 1995 | Supplement 13Manufacturing | Approved | None posted |
| May 4, 1995 | Supplement 12Labeling | Approved | None posted |
| Jun 28, 1994 | Supplement 11Manufacturing | Approved | None posted |
| Dec 7, 1993 | Supplement 10Labeling | Approved | None posted |
| Aug 13, 1993 | Supplement 8Labeling | Approved | None posted |
| Jun 4, 1993 | Supplement 9Manufacturing | Approved | None posted |
| Jun 4, 1993 | Supplement 7Manufacturing | Approved | None posted |
| Jul 30, 1992 | Supplement 6Labeling | Approved | None posted |
| Mar 24, 1992 | Supplement 4Manufacturing | Approved | None posted |
| Feb 27, 1992 | Supplement 5Labeling | Approved | None posted |
| Jul 13, 1989 | Supplement 3Manufacturing | Approved | None posted |
| Jun 16, 1987 | 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
