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