Visitor Monitoring Drug History: AZULFIDINE
 
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Label and Approval History

Drug Name: AZULFIDINE
FDA Application No: (NDA) 007073
Active Ingredient(s): SULFASALAZINE
Company: PHARMACIA AND UPJOHN
 
Label History
 
View the label approved on May 7, 2003 for AZULFIDINE, (NDA) 007073


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
11/12/2002 121Manufacturing Change or Addition  
7/30/2002 120Labeling Revision Letter 
9/26/2000 118Labeling Revision  
2/5/2001 117Package Change  
8/18/2000 116Labeling Revision  
8/17/2001 115Labeling Revision Letter
Label 
4/18/2000 113Labeling Revision  
4/25/2000 112Labeling Revision  
8/13/1999 110Labeling Revision  
4/24/2000 109Labeling Revision  
12/23/1997 107Manufacturing Change or Addition  
5/18/1995 106Manufacturing Change or Addition  
7/25/1996 105Manufacturing Change or Addition  
3/5/1996 104Control Supplement  
6/14/1996 103Package Change  
10/17/1996 102Labeling Revision  
6/14/1996 101Package Change  
3/29/1995 100Manufacturing Change or Addition  
2/21/1996 099Formulation Revision  
12/19/1994 098Control Supplement  
9/28/1995 097Manufacturing Change or Addition  
11/3/1993 096Labeling Revision  
11/2/1993 095Labeling Revision  
10/20/1993 094Manufacturing Change or Addition  
6/8/1994 093Manufacturing Change or Addition  
6/8/1994 092Formulation Revision  
4/5/1993 091Labeling Revision  
4/5/1993 090Labeling Revision  
8/9/1993 089Control Supplement  
8/9/1993 088Control Supplement  
1/26/1994 087Control Supplement  
6/9/1993 086Control Supplement  
6/7/1994 085Control Supplement  
10/20/1993 084Manufacturing Change or Addition  
9/22/1992 083Control Supplement  
11/7/1990 082Labeling Revision  
11/7/1990 081Labeling Revision  
7/10/1991 080Formulation Revision  
7/10/1991 079Formulation Revision  
5/11/1984 077Labeling Revision  
12/12/1983 076Labeling Revision  
1/18/1983 075Package Change  
7/19/1985 074Manufacturing Change or Addition  
7/2/1982 073Manufacturing Change or Addition  
7/15/1982 072Manufacturing Change or Addition  
2/5/1985 071Practioner Draft Labeling  
2/5/1985 070Practioner Draft Labeling  
6/30/1981 065Labeling Revision  
3/25/1981 064Labeling Revision  
3/25/1981 061Labeling Revision  
3/25/1981 060Labeling Revision  
3/5/1981 054Control Supplement  
4/6/1983 020Labeling Revision  
4/6/1983 018Control Supplement  
4/6/1983 017Control Supplement  
6/20/1950 000Approval  
 
Therapeutic Equivalents
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