Visitor Monitoring Drug History: HALDOL
 
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Label and Approval History

Drug Name: HALDOL
FDA Application No: (NDA) 015922
Active Ingredient(s): HALOPERIDOL LACTATE
Company: ORTHO MCNEIL
 
Label History
 
Labels are not available on this site for HALDOL, (NDA) 015922
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/17/2002 066Labeling Revision  
5/2/2000 065Labeling Revision  
5/10/1996 062Manufacturing Change or Addition  
4/23/1998 061Control Supplement  
1/30/1995 059Manufacturing Change or Addition  
6/29/1994 058Control Supplement  
7/7/1989 056Manufacturing Change or Addition  
4/13/1988 053Package Change  
7/14/1988 052Manufacturing Change or Addition  
10/22/1986 043Package Change  
10/22/1986 042Package Change  
1/8/1987 040Package Change  
1/14/1986 037Package Change  
1/14/1986 036Package Change  
1/14/1986 035Package Change  
1/14/1986 033Package Change  
3/11/1983 028Labeling Revision  
1/31/1983 027Labeling Revision  
9/8/1982 026Labeling Revision  
4/20/1982 025Manufacturing Change or Addition  
6/23/1982 024Manufacturing Change or Addition  
10/2/1981 023Labeling Revision  
1/23/1981 021Labeling Revision  
1/23/1981 020Labeling Revision  
5/19/1980 019Package Change  
7/28/1980 018Manufacturing Change or Addition  
7/6/1979 017Labeling Revision  
1/15/1980 016Manufacturing Change or Addition  
7/6/1979 015Labeling Revision  
2/12/1980 014Labeling Revision  
4/12/1979 013Manufacturing Change or Addition  
2/13/1978 012Labeling Revision  
4/12/1967 000Approval  
 
Therapeutic Equivalents
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