Drug History: KEFLEX

DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST

Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9

Label and Approval History

Drug Name:	KEFLEX
FDA Application No:	(NDA) 050405
Active Ingredient(s):	CEPHALEXIN
Company:	MIDDLEBROOK PHARMS

Label History

View the label approved on May 16, 2006 for KEFLEX, (NDA) 050405

To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.

Approval History

Action Date	Supplement Number	Approval Type	Letters, Reviews, Labels, Patient Package Insert
5/12/2006	097	Efficacy Supplement with Clinical Data to Support	Letter Label
6/25/2004	095	Labeling Revision	Letter
1/15/2004	094	Labeling Revision	Letter Label
10/23/2002	093	Control Supplement
11/19/2004	092	Labeling Revision	Letter
7/27/2001	091	Manufacturing Change or Addition
5/15/1996	090	Labeling Revision
2/13/1995	089	Labeling Revision
11/4/1988	088	Manufacturing Change or Addition
5/25/1977	087	Manufacturing Change or Addition
4/28/1977	086	Expiration Date Change
4/22/1977	085	Labeling Revision
3/15/1977	084	Control Supplement
3/9/1977	083	Control Supplement
2/28/1977	082	Labeling Revision
12/17/1976	081	Labeling Revision
12/10/1976	080	Control Supplement
12/10/1976	079	Control Supplement
9/8/1976	078	Labeling Revision
9/8/1976	077	Labeling Revision
9/2/1976	076	Labeling Revision
8/10/1976	075	Control Supplement
6/8/1976	074	Labeling Revision
4/22/1976	073	Labeling Revision
4/9/1976	072	Labeling Revision
3/10/1976	071	Control Supplement
3/10/1976	070	Control Supplement
11/17/1975	069	Labeling Revision
10/24/1975	068	Labeling Revision
9/16/1975	065	Labeling Revision
9/8/1975	064	Labeling Revision
9/4/1975	063	Labeling Revision
8/12/1975	062	Labeling Revision
8/4/1975	061	Labeling Revision
7/31/1975	060	Control Supplement
7/8/1975	059	Labeling Revision
4/7/1975	057	Expiration Date Change
12/13/1974	056	Labeling Revision
10/2/1974	055	Labeling Revision
9/3/1974	054	Labeling Revision
10/4/1974	053	New or Modified Indication
8/28/1974	052	Labeling Revision
8/22/1974	051	Labeling Revision
8/16/1974	050	Labeling Revision
7/10/1974	049	Formulation Revision
5/24/1974	048	Labeling Revision
6/28/1974	047	Labeling Revision
3/6/1974	046	Labeling Revision
2/20/1974	045	Expiration Date Change
1/24/1974	044	Control Supplement
1/15/1974	043	Control Supplement
11/8/1973	042	Expiration Date Change
10/2/1973	041	Labeling Revision
7/31/1973	040	Labeling Revision
7/25/1973	039	Control Supplement
6/25/1973	038	Labeling Revision
6/19/1973	037	Labeling Revision
6/4/1973	036	Labeling Revision
4/27/1973	035	Labeling Revision
2/15/1973	034	Control Supplement
1/18/1973	033	Control Supplement
12/13/1972	032	Labeling Revision
7/19/1972	031	Control Supplement
12/13/1972	030	Labeling Revision
2/24/1972	029	Labeling Revision
1/12/1972	028	Control Supplement
12/13/1971	027	Control Supplement
11/30/1971	025	Control Supplement
10/6/1971	024	Labeling Revision
10/19/1971	023	Expiration Date Change
7/1/1971	022	Labeling Revision
5/19/1971	021	Labeling Revision
5/13/1971	020	Labeling Revision
4/14/1971	019	Labeling Revision
1/7/1971	018	Manufacturing Change or Addition
10/9/1991	016	Control Supplement
8/27/1992	015	Labeling Revision
4/10/1990	014	Labeling Revision
9/21/1988	013	Labeling Revision
2/17/1987	012	New or Modified Indication
3/4/1987	011	Labeling Revision
3/4/1987	010	Manufacturing Change or Addition
8/29/1986	009	Labeling Revision
8/6/1971	008	Labeling Revision
7/7/1971	007	Labeling Revision
8/21/1986	005	New or Modified Indication
11/22/1985	004	Labeling Revision
11/4/1985	003	Control Supplement
2/8/1971	002	Control Supplement
9/5/1984	001	Control Supplement
1/4/1971	000	Approval

Therapeutic Equivalents