Visitor Monitoring Drug History: HALDOL
 
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: HALDOL
FDA Application No: (NDA) 015923
Active Ingredient(s): HALOPERIDOL LACTATE
Company: ORTHO MCNEIL
 
Label History
 
View the label approved on May 7, 2007 for HALDOL, (NDA) 015923


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 080Labeling Revision Letter 
5/4/2007 078Labeling Revision Letter
Label 
12/10/2002 073Manufacturing Change or Addition  
4/17/2002 072Labeling Revision Review 
11/7/2000 071Manufacturing Change or Addition  
4/13/2000 070Manufacturing Change or Addition  
3/16/2000 069Manufacturing Change or Addition  
1/26/2000 068Manufacturing Change or Addition  
5/2/2000 066Labeling Revision  
5/10/1996 063Manufacturing Change or Addition  
4/23/1998 062Control Supplement  
12/5/1994 060Manufacturing Change or Addition  
1/30/1995 059Manufacturing Change or Addition  
6/29/1994 058Control Supplement  
2/23/1990 056Manufacturing Change or Addition  
2/14/1990 055Control Supplement  
8/28/1996 054Labeling Revision  
6/2/1988 052Manufacturing Change or Addition  
5/2/1988 051Manufacturing Change or Addition  
3/28/1988 050Manufacturing Change or Addition  
2/12/1988 049Manufacturing Change or Addition  
7/27/1988 048Manufacturing Change or Addition  
4/25/1988 047Manufacturing Change or Addition  
1/30/1987 040Manufacturing Change or Addition  
1/30/1987 038Manufacturing Change or Addition  
4/7/1986 032Manufacturing Change or Addition  
10/29/1984 029Expiration Date Change  
3/11/1983 027Labeling Revision  
1/31/1983 024Labeling Revision  
9/8/1982 023Labeling Revision  
4/20/1981 020Manufacturing Change or Addition  
6/23/1982 019Manufacturing Change or Addition  
10/2/1981 018Labeling Revision  
1/23/1981 016Labeling Revision  
1/23/1981 015Labeling Revision  
1/22/1980 014Manufacturing Change or Addition  
7/6/1979 013Labeling Revision  
10/2/1981 012Labeling Revision  
2/12/1980 011Labeling Revision  
2/13/1978 009Labeling Revision  
12/3/1975 008Control Supplement  
12/3/1975 004Final Printed Labeling - MarkIV  
5/18/1971 000Approval  
 
Therapeutic Equivalents
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