Visitor Monitoring Drug History: IMODIUM
 
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: IMODIUM
FDA Application No: (NDA) 017694
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
Company: MCNEIL PED
 
Label History
 
View the label approved on October 25, 2005 for IMODIUM, (NDA) 017694


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
10/21/2005 050Labeling Revision Letter
Label 
10/13/1999 048Package Change  
3/1/1999 047Labeling Revision  
6/30/1998 045Manufacturing Change or Addition  
6/2/1998 044Control Supplement  
9/1/1998 043Manufacturing Change or Addition  
10/5/1995 042Manufacturing Change or Addition  
6/1/1993 041Labeling Revision  
8/24/1993 040Manufacturing Change or Addition  
6/17/1999 039Control Supplement  
10/2/1992 038Control Supplement  
4/15/1988 037Labeling Revision  
5/26/1988 036Control Supplement  
6/16/1987 035Labeling Revision  
9/16/1986 034Control Supplement  
9/20/1985 033Manufacturing Change or Addition  
10/29/1985 032Labeling Revision  
8/2/1984 031Control Supplement  
8/2/1984 030Package Change  
11/22/1983 029Manufacturing Change or Addition  
7/15/1983 028Control Supplement  
2/15/1983 027Labeling Revision  
12/15/1982 026Control Supplement  
11/3/1982 025Package Change  
11/3/1982 024Package Change  
4/27/1983 022Labeling Revision  
5/19/1982 021Control Supplement  
8/10/1982 020Manufacturing Change or Addition  
7/31/1984 019Practioner Draft Labeling  
5/14/1981 018Control Supplement  
5/11/1981 017Labeling Revision  
6/13/1980 016Manufacturing Change or Addition  
3/26/1980 015Manufacturing Change or Addition  
11/5/1979 014Labeling Revision  
10/3/1979 013Control Supplement  
5/23/1979 012Labeling Revision  
6/25/1979 011Labeling Revision  
4/5/1979 010Package Change  
4/5/1979 009Labeling Revision  
3/14/1979 008Package Change  
10/30/1978 007Formulation Revision  
10/30/1978 006Control Supplement  
7/5/1978 005Labeling Revision  
4/24/1978 003Control Supplement  
9/14/1978 001Labeling Revision  
12/28/1976 000Approval  
 
Therapeutic Equivalents
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