Visitor Monitoring Drug History: HUMULIN R
 
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Label and Approval History

Drug Name: HUMULIN R
FDA Application No: (NDA) 018780
Active Ingredient(s): INSULIN RECOMBINANT HUMAN
Company: LILLY
 
Label History
 
View the label approved on September 11, 2007 for HUMULIN R, (NDA) 018780


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
9/10/2007 114Labeling Revision Letter
Label 
8/22/2007 095Labeling Revision Letter
Label 
9/7/2007 094Labeling Revision Letter 
2/25/2005 086Control Supplement Letter
Label 
11/10/2003 080Manufacturing Change or Addition Letter
Label 
2/10/2003 078Manufacturing Change or Addition Letter
Label 
10/25/2002 076Control Supplement  
8/29/2002 075Control Supplement  
8/29/2002 074Control Supplement  
8/29/2002 073Control Supplement  
8/21/2002 072Control Supplement  
8/21/2002 071Control Supplement  
10/10/2002 070Control Supplement  
3/13/2002 069Control Supplement  
2/10/2003 067Labeling Revision Letter
Label 
4/14/2003 066Labeling Revision Letter 
8/29/2002 065Control Supplement  
4/19/2000 064Control Supplement  
11/2/1999 063Control Supplement  
2/25/1999 061Control Supplement  
8/6/1998 058Package Change  
2/20/1998 057Control Supplement  
4/16/1997 056Control Supplement  
4/16/1997 055Labeling Revision  
1/28/1997 054Manufacturing Change or Addition  
7/26/1996 052Control Supplement  
7/10/1996 051Labeling Revision  
7/26/1996 050Control Supplement  
4/25/1996 049Manufacturing Change or Addition  
2/15/1996 048Control Supplement  
2/14/1996 047Control Supplement  
11/9/1995 046Labeling Revision  
9/29/1995 045Labeling Revision  
3/9/1995 044Control Supplement  
2/22/1995 043Labeling Revision  
3/31/1994 042New Dosage Regimen  
12/7/1992 041Package Change  
5/10/1993 040Manufacturing Change or Addition  
6/14/1994 039Control Supplement  
1/27/1992 038Labeling Revision  
1/11/1994 037Package Change Review 
3/12/1991 036Labeling Revision  
11/15/1991 035Control Supplement  
9/24/1990 034Control Supplement  
8/17/1990 033Control Supplement  
1/23/1989 032Labeling Revision  
7/29/1988 031Control Supplement  
2/1/1989 030Control Supplement  
3/24/1988 029Labeling Revision  
10/27/1987 028Manufacturing Change or Addition  
6/10/1988 027Control Supplement  
7/10/1987 026Labeling Revision  
5/28/1986 024Control Supplement  
7/13/1987 023Labeling Revision  
5/7/1987 022Control Supplement  
7/28/1987 021Labeling Revision  
9/15/1986 020Control Supplement  
4/10/1986 018Control Supplement  
3/8/1985 016Control Supplement  
11/23/1984 014Control Supplement  
12/26/1984 013Control Supplement  
2/28/1984 012Labeling Revision  
1/26/1984 011Control Supplement  
7/25/1984 009Control Supplement  
10/12/1983 008Labeling Revision  
8/24/1983 007Labeling Revision  
3/14/1983 005Control Supplement  
1/27/1983 004Labeling Revision  
1/31/1983 003Control Supplement  
12/2/1982 002Formulation Revision  
12/2/1982 001Labeling Revision  
10/28/1982 000Approval  
 
Therapeutic Equivalents
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