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Keflex

NDA 50405, held by Pragma. Cephalexin.

As of Nov 14, 2026, NDA 50405 (Keflex), held by Pragma, was first approved by FDA on Jan 4, 1971, with 98 approved supplements and 0 published complete response letters.

First approved: Jan 4, 1971
Supplements approved: 98
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 99 submissions below


May 12, 2006	Supplement 97Efficacy (new indication or use)	Approved	Letter Label
Feb 17, 1987	Supplement 12Efficacy (new indication or use)	Approved	None posted
Aug 21, 1986	Supplement 5Efficacy (new indication or use)	Approved	None posted
Oct 4, 1974	Supplement 53Efficacy (new indication or use)	Approved	None posted
Jan 4, 1971	Original application	Approved	None posted

Products

4 strengths and forms


KeflexEQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cephalexin	DiscontinuedReference drug
KeflexEQ 500MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cephalexin	DiscontinuedReference drug
KeflexEQ 333MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cephalexin	DiscontinuedReference drug
KeflexEQ 750MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · capsule;oral	Cephalexin	DiscontinuedReference drug

All 99 submissions, including labeling and manufacturing supplements


Aug 3, 2026	Supplement 111Labeling · Standard review	Approved	Label Letter
Sep 6, 2019	Supplement 110Labeling · Standard review	Approved	Label
Dec 19, 2018	Supplement 108Labeling · Standard review	Approved	Letter Label
Dec 18, 2018	Supplement 107Labeling · Standard review	Approved	Letter Label
Oct 30, 2015	Supplement 106Labeling · Standard review	Approved	Letter Label
Dec 30, 2013	Supplement 104Manufacturing	Approved	None posted
Sep 16, 2008	Supplement 101Labeling · Standard review	Approved	Letter
May 21, 2008	Supplement 99Labeling · Standard review	Approved	Letter
May 12, 2006	Supplement 97Efficacy (new indication or use)	Approved	Letter Label
Nov 19, 2004	Supplement 92Labeling · Standard review	Approved	Letter
Jun 25, 2004	Supplement 95Labeling · Standard review	Approved	Letter
Jan 15, 2004	Supplement 94Labeling · Standard review	Approved	Letter Label
Oct 23, 2002	Supplement 93Manufacturing	Approved	None posted
Jul 27, 2001	Supplement 91Manufacturing	Approved	None posted
May 15, 1996	Supplement 90Labeling · Standard review	Approved	None posted
Feb 13, 1995	Supplement 89Labeling · Standard review	Approved	None posted
Aug 27, 1992	Supplement 15Labeling	Approved	None posted
Oct 9, 1991	Supplement 16Manufacturing	Approved	None posted
Apr 10, 1990	Supplement 14Labeling	Approved	None posted
Nov 4, 1988	Supplement 88Manufacturing	Approved	None posted
Sep 21, 1988	Supplement 13Labeling	Approved	None posted
Mar 4, 1987	Supplement 11Labeling	Approved	None posted
Mar 4, 1987	Supplement 10Manufacturing	Approved	None posted
Feb 17, 1987	Supplement 12Efficacy (new indication or use)	Approved	None posted
Aug 29, 1986	Supplement 9Labeling	Approved	None posted
Aug 21, 1986	Supplement 5Efficacy (new indication or use)	Approved	None posted
Nov 22, 1985	Supplement 4Labeling	Approved	None posted
Nov 4, 1985	Supplement 3Manufacturing	Approved	None posted
Sep 5, 1984	Supplement 1Manufacturing	Approved	None posted
May 25, 1977	Supplement 87Manufacturing	Approved	None posted
Apr 28, 1977	Supplement 86Manufacturing	Approved	None posted
Apr 22, 1977	Supplement 85Labeling	Approved	None posted
Mar 15, 1977	Supplement 84Manufacturing	Approved	None posted
Mar 9, 1977	Supplement 83Manufacturing	Approved	None posted
Feb 28, 1977	Supplement 82Labeling	Approved	None posted
Dec 17, 1976	Supplement 81Labeling	Approved	None posted
Dec 10, 1976	Supplement 80Manufacturing	Approved	None posted
Dec 10, 1976	Supplement 79Manufacturing	Approved	None posted
Sep 8, 1976	Supplement 78Labeling	Approved	None posted
Sep 8, 1976	Supplement 77Labeling	Approved	None posted
Sep 2, 1976	Supplement 76Labeling	Approved	None posted
Aug 10, 1976	Supplement 75Manufacturing	Approved	None posted
Jun 8, 1976	Supplement 74Labeling	Approved	None posted
Apr 22, 1976	Supplement 73Labeling	Approved	None posted
Apr 9, 1976	Supplement 72Labeling	Approved	None posted
Mar 10, 1976	Supplement 71Manufacturing	Approved	None posted
Mar 10, 1976	Supplement 70Manufacturing	Approved	None posted
Nov 17, 1975	Supplement 69Labeling	Approved	None posted
Oct 24, 1975	Supplement 68Labeling	Approved	None posted
Sep 16, 1975	Supplement 65Labeling	Approved	None posted
Sep 8, 1975	Supplement 64Labeling	Approved	None posted
Sep 4, 1975	Supplement 63Labeling	Approved	None posted
Aug 12, 1975	Supplement 62Labeling	Approved	None posted
Aug 4, 1975	Supplement 61Labeling	Approved	None posted
Jul 31, 1975	Supplement 60Manufacturing	Approved	None posted
Jul 8, 1975	Supplement 59Labeling	Approved	None posted
Apr 7, 1975	Supplement 57Manufacturing	Approved	None posted
Dec 13, 1974	Supplement 56Labeling	Approved	None posted
Oct 4, 1974	Supplement 53Efficacy (new indication or use)	Approved	None posted
Oct 2, 1974	Supplement 55Labeling	Approved	None posted
Sep 3, 1974	Supplement 54Labeling	Approved	None posted
Aug 28, 1974	Supplement 52Labeling	Approved	None posted
Aug 22, 1974	Supplement 51Labeling	Approved	None posted
Aug 16, 1974	Supplement 50Labeling	Approved	None posted
Jul 10, 1974	Supplement 49Manufacturing	Approved	None posted
Jun 28, 1974	Supplement 47Labeling	Approved	None posted
May 24, 1974	Supplement 48Labeling	Approved	None posted
Mar 6, 1974	Supplement 46Labeling	Approved	None posted
Feb 20, 1974	Supplement 45Manufacturing	Approved	None posted
Jan 24, 1974	Supplement 44Manufacturing	Approved	None posted
Jan 15, 1974	Supplement 43Manufacturing	Approved	None posted
Nov 8, 1973	Supplement 42Manufacturing	Approved	None posted
Oct 2, 1973	Supplement 41Labeling	Approved	None posted
Jul 31, 1973	Supplement 40Labeling	Approved	None posted
Jul 25, 1973	Supplement 39Manufacturing	Approved	None posted
Jun 25, 1973	Supplement 38Labeling	Approved	None posted
Jun 19, 1973	Supplement 37Labeling	Approved	None posted
Jun 4, 1973	Supplement 36Labeling	Approved	None posted
Apr 27, 1973	Supplement 35Labeling	Approved	None posted
Feb 15, 1973	Supplement 34Manufacturing	Approved	None posted
Jan 18, 1973	Supplement 33Manufacturing	Approved	None posted
Dec 13, 1972	Supplement 32Labeling	Approved	None posted
Dec 13, 1972	Supplement 30Labeling	Approved	None posted
Jul 19, 1972	Supplement 31Manufacturing	Approved	None posted
Feb 24, 1972	Supplement 29Labeling	Approved	None posted
Jan 12, 1972	Supplement 28Manufacturing	Approved	None posted
Dec 13, 1971	Supplement 27Manufacturing	Approved	None posted
Nov 30, 1971	Supplement 25Manufacturing	Approved	None posted
Oct 19, 1971	Supplement 23Manufacturing	Approved	None posted
Oct 6, 1971	Supplement 24Labeling	Approved	None posted
Aug 6, 1971	Supplement 8Labeling	Approved	None posted
Jul 7, 1971	Supplement 7Labeling	Approved	None posted
Jul 1, 1971	Supplement 22Labeling	Approved	None posted
May 19, 1971	Supplement 21Labeling	Approved	None posted
May 13, 1971	Supplement 20Labeling	Approved	None posted
Apr 14, 1971	Supplement 19Labeling	Approved	None posted
Feb 8, 1971	Supplement 2Manufacturing	Approved	None posted
Jan 7, 1971	Supplement 18Manufacturing	Approved	None posted
Jan 4, 1971	Original application	Approved	None posted

Show all 99

Identifiers

Application: NDA 50405
Drugs@FDA: Overview at FDA
Company: Pragma

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