Visitor Monitoring Drug History: MAXITROL
 
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: MAXITROL
FDA Application No: (NDA) 050065
Active Ingredient(s): DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Company: FALCON PHARMS
 
Label History
 
View the label approved on July 21, 2004 for MAXITROL, (NDA) 050065


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
7/15/2004 044Package Change Letter
Label 
7/15/2004 043Labeling Revision Letter
Label 
12/11/2002 041Control Supplement  
7/23/2003 040Labeling Revision Letter
Label 
7/23/2003 039Manufacturing Change or Addition Letter
Label 
2/9/2001 038Manufacturing Change or Addition  
9/28/1999 037Package Change  
4/7/1999 036Manufacturing Change or Addition  
2/5/1999 035Manufacturing Change or Addition  
5/29/1998 034Manufacturing Change or Addition  
11/29/1996 032Control Supplement  
3/18/1996 031Control Supplement  
5/18/1995 030Formulation Revision  
8/30/1995 029Labeling Revision  
7/11/1983 028Control Supplement  
7/29/1982 027Labeling Revision  
6/17/1981 026Control Supplement  
4/13/1981 025Control Supplement  
5/10/1978 024Labeling Revision  
2/20/1973 023Control Supplement  
2/8/1973 022Control Supplement  
2/8/1973 021Control Supplement  
9/19/1972 020Labeling Revision  
7/12/1972 019Control Supplement  
4/17/1972 018Control Supplement  
4/10/1972 017Package Change  
8/9/1971 016Labeling Revision  
7/22/1971 015Labeling Revision  
6/4/1970 014Control Supplement  
2/3/1992 013Control Supplement  
9/17/1992 010Package Change  
3/22/1988 009Control Supplement  
5/15/1987 008Labeling Revision  
6/30/1987 007Labeling Revision  
6/30/1987 006Manufacturing Change or Addition  
7/25/1984 005Control Supplement  
4/23/1984 004Control Supplement  
12/30/1983 003Labeling Revision  
11/23/1983 002Control Supplement  
7/11/1983 001Control Supplement  
7/19/1963 000Approval  
 
There are no Therapeutic Equivalents
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