Visitor Monitoring Drug History: NOLVADEX
 
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Label and Approval History

Drug Name: NOLVADEX
FDA Application No: (NDA) 017970
Active Ingredient(s): TAMOXIFEN CITRATE
Company: ASTRAZENECA
 
Label History
 
View the label approved on March 14, 2006 for NOLVADEX, (NDA) 017970


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
3/9/2006 054Efficacy Supplement with Clinical Data to Support Letter
Label 
3/17/2005 053Labeling Revision Letter
Label 
12/14/2004 052Labeling Revision Letter
Label 
1/30/2003 051Labeling Revision Letter
Label
Review 
8/30/2002 050Labeling Revision Letter
Label
Review 
5/16/2002 049Labeling Revision Letter
Label
Review 
6/10/2003 048Labeling Revision Letter
Label 
12/14/2000 047Manufacturing Change or Addition  
6/29/2000 046New or Modified Indication Letter
Label
Review 
4/24/2000 045Manufacturing Change or Addition  
5/16/2002 044Labeling Revision Letter
Label 
4/2/1999 043Labeling Revision  
10/30/1998 041Labeling Revision  
10/29/1998 040New or Modified Indication Letter
Label
Review 
10/29/1998 039New or Modified Indication Letter
Label
Review 
6/11/1998 038Control Supplement  
5/16/2002 037Labeling Revision Letter
Label 
11/4/1996 036Package Change  
11/15/1996 035Labeling Revision  
3/26/1996 034Labeling Revision  
1/23/1996 033Labeling Revision  
1/23/1996 032Labeling Revision  
1/23/1996 031Labeling Revision  
2/1/1995 030Labeling Revision  
3/21/1994 027New Dosage Regimen Label 
4/1/1993 024Patient Population Altered Label 
3/14/1991 021Control Supplement  
6/21/1990 020New or Modified Indication Label 
3/16/1989 018New or Modified Indication Label 
11/25/1987 017Labeling Revision  
12/3/1986 015New or Modified Indication Label 
4/5/1984 011Control Supplement  
12/18/1984 010Package Change  
8/20/1985 009Practioner Draft Labeling  
12/10/1985 008Labeling Revision  
3/29/1982 006Labeling Revision  
12/18/1979 005Control Supplement  
10/2/1978 004Control Supplement  
7/31/1979 003Labeling Revision  
7/24/1979 002Expiration Date Change  
5/25/1978 001Manufacturing Change or Addition  
12/30/1977 000Approval Label 
 
Therapeutic Equivalents
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