NDA 50406, held by Pragma. Cephalexin.
As of Nov 14, 2026, NDA 50406 (Keflex), held by Pragma, was first approved by FDA on Jan 4, 1971, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 4, 1971 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| KeflexEQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · for suspension;oral | Cephalexin | DiscontinuedReference drug |
| KeflexEQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · for suspension;oral | Cephalexin | DiscontinuedReference drug |
| KeflexEQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* · for suspension;oral | Cephalexin | DiscontinuedReference drug |
| Mar 5, 2026 | Supplement 14Labeling · Standard review | Approved | |
| Dec 18, 2018 | Supplement 13Labeling · Standard review | Approved | |
| May 19, 2009 | Supplement 11Labeling · Standard review | Approved | None posted |
| May 15, 1996 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 13, 1995 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 27, 1992 | Supplement 8Labeling | Approved | None posted |
| Apr 10, 1990 | Supplement 7Labeling | Approved | None posted |
| Jan 4, 1971 | Original applicationNew formulation or manufacturer · Standard review | 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
