Visitor Monitoring Drug History: LYOPHILIZED CYTOXAN
 
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: LYOPHILIZED CYTOXAN
FDA Application No: (NDA) 012142
Active Ingredient(s): CYCLOPHOSPHAMIDE
Company: BRISTOL MYERS SQUIBB
 
Label History
 
View the label approved on January 9, 2004 for LYOPHILIZED CYTOXAN, (NDA) 012142


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
11/7/2003 107Formulation Revision Letter 
11/2/2000 104Manufacturing Change or Addition  
1/30/2001 103Labeling Revision  
5/28/1999 102Labeling Revision  
6/15/2000 101Labeling Revision Label 
12/20/1995 098Labeling Revision  
10/22/1990 093Control Supplement  
3/1/1989 092Control Supplement  
1/12/1988 091Control Supplement  
1/11/1988 090Labeling Revision  
11/20/1987 089Control Supplement  
4/29/1987 088Manufacturing Change or Addition  
12/8/1986 087Labeling Revision  
12/8/1986 086Labeling Revision  
5/30/1986 085Labeling Revision  
5/30/1986 084Labeling Revision  
7/11/1986 083Labeling Revision  
7/11/1986 082Labeling Revision  
7/11/1986 081Labeling Revision  
5/30/1986 080Labeling Revision  
4/28/1988 079Control Supplement  
2/14/1986 077Labeling Revision  
8/30/1985 076Labeling Revision  
8/30/1985 075Control Supplement  
5/2/1985 074Expiration Date Change  
6/18/1985 073Control Supplement  
5/6/1985 072Expiration Date Change  
12/10/1984 071Expiration Date Change  
12/10/1985 070Labeling Revision  
9/24/1985 069Labeling Revision  
12/5/1985 068Labeling Revision  
7/18/1984 067Expiration Date Change  
6/15/1984 066Manufacturing Change or Addition  
8/20/1984 065Control Supplement  
5/24/1984 064Control Supplement  
6/14/1984 063Labeling Revision  
10/17/1984 061Labeling Revision  
4/5/1984 059Labeling Revision  
1/4/1984 058Formulation Revision  
8/6/1985 057Control Supplement  
3/15/1983 056Labeling Revision  
6/14/1984 055Package Change  
8/30/1982 054Package Change  
4/29/1987 053Practioner Draft Labeling  
7/28/1982 052Control Supplement  
10/13/1981 050Control Supplement  
11/16/1981 048Control Supplement  
12/11/1981 047Package Change  
3/21/1981 046Package Change  
9/27/1980 045Labeling Revision  
8/3/1979 044Control Supplement  
6/19/1979 043Manufacturing Change or Addition  
2/16/1979 041Control Supplement  
12/13/1978 040Control Supplement  
12/3/1979 039Control Supplement  
8/29/1978 038Control Supplement  
4/20/1977 035Control Supplement  
4/26/1977 034Control Supplement  
4/26/1977 033Manufacturing Change or Addition  
11/1/1976 030Labeling Revision  
6/10/1976 029Manufacturing Change or Addition  
4/29/1987 028New or Modified Indication  
1/13/1976 025Control Supplement  
11/16/1959 000Approval  
 
Therapeutic Equivalents
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