ANDA 62703, held by Teva. Cephalexin.
As of Nov 13, 2026, ANDA 62703 (Cephalexin), held by Teva, was first approved by FDA on Feb 13, 1987, with 28 approved supplements and 0 published complete response letters.
Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection Otitis media Skin and skin structure infections Bone infections Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets and other antibacterial drugs, cephalexin capsules, cephalexin for oral suspension, and cephalexin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 1987 | Original application | Approved | None posted |
| CephalexinEQ 125MG BASE/5ML · for suspension;oral | Cephalexin | Rx |
| CephalexinEQ 250MG BASE/5ML · for suspension;oral | Cephalexin | Rx |
| Aug 21, 2012 | Supplement 54Labeling · Standard review | Approved | None posted |
| Feb 22, 2011 | Supplement 52Labeling | Approved | None posted |
| Nov 16, 2009 | Supplement 51Labeling | Approved | None posted |
| Sep 27, 2007 | Supplement 49Labeling | Approved | None posted |
| Feb 9, 2007 | Supplement 47Labeling | Approved | None posted |
| Jan 13, 2004 | Supplement 40Labeling | Approved | None posted |
| Jan 13, 2004 | Supplement 39Labeling | Approved | None posted |
| Aug 1, 2002 | Supplement 35Manufacturing | Approved | None posted |
| Jun 18, 2002 | Supplement 34Manufacturing | Approved | None posted |
| Feb 20, 2002 | Supplement 32Manufacturing | Approved | None posted |
| Aug 14, 2001 | Supplement 33Manufacturing | Approved | None posted |
| Jul 7, 2000 | Supplement 31Manufacturing | Approved | None posted |
| Jan 18, 2000 | Supplement 30Manufacturing | Approved | None posted |
| Jul 21, 1998 | Supplement 29Manufacturing | Approved | None posted |
| Aug 19, 1997 | Supplement 28Manufacturing | Approved | None posted |
| Oct 4, 1996 | Supplement 27Manufacturing | Approved | None posted |
| May 10, 1996 | Supplement 26Manufacturing | Approved | None posted |
| Nov 27, 1995 | Supplement 25Manufacturing | Approved | None posted |
| Jul 17, 1995 | Supplement 23Manufacturing | Approved | None posted |
| Feb 16, 1995 | Supplement 24Manufacturing | Approved | None posted |
| Sep 6, 1994 | Supplement 22Manufacturing | Approved | None posted |
| Oct 13, 1993 | Supplement 21Labeling | Approved | None posted |
| Oct 27, 1988 | Supplement 20Manufacturing | Approved | None posted |
| Sep 30, 1988 | Supplement 18Manufacturing | Approved | None posted |
| Sep 14, 1988 | Supplement 19Manufacturing | Approved | None posted |
| Aug 25, 1988 | Supplement 16Manufacturing | Approved | None posted |
| Aug 4, 1988 | Supplement 17Manufacturing | Approved | None posted |
| May 31, 1988 | Supplement 15Manufacturing | Approved | None posted |
| Feb 13, 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
