Visitor Monitoring Drug History: HALDOL
 
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Label and Approval History

Drug Name: HALDOL
FDA Application No: (NDA) 018701
Active Ingredient(s): HALOPERIDOL DECANOATE
Company: ORTHO MCNEIL
 
Label History
 
View the label approved on May 7, 2007 for HALDOL, (NDA) 018701


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
9/19/2007 055Labeling Revision Letter 
5/4/2007 053Labeling Revision Letter
Label 
4/17/2002 046Labeling Revision Review 
4/13/2000 045Manufacturing Change or Addition  
5/2/2000 043Labeling Revision  
6/23/1998 041Package Change  
9/11/1997 040Manufacturing Change or Addition  
5/10/1996 039Manufacturing Change or Addition  
9/7/1994 038Manufacturing Change or Addition  
5/22/1995 037Manufacturing Change or Addition  
4/27/1993 036Labeling Revision  
6/29/1994 035Control Supplement  
4/21/1993 034Labeling Revision  
12/21/1990 033Manufacturing Change or Addition  
10/31/1989 032Labeling Revision  
5/10/1989 031Manufacturing Change or Addition  
2/16/1989 030Package Change  
1/31/1997 029Labeling Revision  
1/31/1997 028Manufacturing Change or Addition  
1/19/1989 027Labeling Revision  
10/20/1988 025Labeling Revision  
10/20/1988 024Manufacturing Change or Addition  
1/18/1989 023Control Supplement  
1/18/1989 022Control Supplement  
6/17/1988 021Manufacturing Change or Addition  
9/28/1987 019Labeling Revision  
8/24/1988 018Manufacturing Change or Addition  
8/24/1988 015Manufacturing Change or Addition  
11/18/1986 012Labeling Revision  
1/28/1987 011Labeling Revision  
1/28/1987 010Manufacturing Change or Addition  
1/28/1987 009Labeling Revision  
1/28/1987 008Manufacturing Change or Addition  
10/28/1986 007Labeling Revision  
6/15/1987 006Labeling Revision  
6/15/1987 005Manufacturing Change or Addition  
6/15/1987 004Manufacturing Change or Addition  
2/24/1987 003Labeling Revision  
6/10/1986 002Control Supplement  
1/14/1986 000Approval  
 
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