Visitor Monitoring Drug History: HALDOL
 
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Label and Approval History

Drug Name: HALDOL
FDA Application No: (NDA) 015921
Active Ingredient(s): HALOPERIDOL
Company: ORTHO MCNEIL
 
Label History
 
Labels are not available on this site for HALDOL, (NDA) 015921
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/17/2002 076Labeling Revision  
5/2/2000 075Labeling Revision  
5/10/1996 072Manufacturing Change or Addition  
4/23/1998 071Control Supplement  
1/30/1995 068Manufacturing Change or Addition  
6/29/1994 067Control Supplement  
4/6/1990 065Manufacturing Change or Addition  
10/4/1988 062Manufacturing Change or Addition  
2/17/1988 061Expiration Date Change  
10/16/1987 059Manufacturing Change or Addition  
10/22/1986 053Package Change  
2/6/1986 048Package Change  
4/30/1985 047Package Change  
4/30/1985 046Manufacturing Change or Addition  
3/18/1983 040Package Change  
3/18/1983 039Package Change  
3/18/1983 038Package Change  
3/11/1983 037Labeling Revision  
1/31/1983 036Labeling Revision  
9/8/1982 035Labeling Revision  
9/3/1982 034Control Supplement  
4/20/1982 033Manufacturing Change or Addition  
6/23/1982 032Manufacturing Change or Addition  
10/2/1981 031Labeling Revision  
1/23/1981 029Labeling Revision  
1/23/1981 028Labeling Revision  
3/7/1980 027Package Change  
2/2/1982 026Manufacturing Change or Addition  
7/6/1979 025Labeling Revision  
2/12/1980 024Labeling Revision  
12/12/1977 023Manufacturing Change or Addition  
2/13/1978 021Labeling Revision  
3/26/1976 020Control Supplement  
12/10/1974 019Control Supplement  
5/21/1974 012Other Amendment  
4/12/1967 000Approval  
 
Therapeutic Equivalents
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