Visitor Monitoring Drug History: IMODIUM A-D
 
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Label and Approval History

Drug Name: IMODIUM A-D
FDA Application No: (NDA) 019487
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
Company: MCNEIL CONS
 
Label History
 
Labels are not available on this site for IMODIUM AD, (NDA) 019487
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
6/8/2005 023Package Change Letter 
7/8/2004 022Formulation Revision Letter 
6/16/2004 021Labeling Revision Letter 
12/3/1999 018Manufacturing Change or Addition  
9/4/1998 016Package Change  
10/28/1996 015Labeling Revision  
3/22/1996 014Labeling Revision  
2/12/1996 013Package Change  
8/15/1994 012Labeling Revision  
7/16/1992 011Package Change  
5/17/1991 009Package Change  
5/13/1993 008Formulation Revision  
11/23/1992 007New or Modified Indication  
2/9/1990 006Manufacturing Change or Addition  
1/29/1990 005Manufacturing Change or Addition  
1/5/1989 004Manufacturing Change or Addition  
12/6/1988 001Package Change  
3/1/1988 000Approval  
 
Therapeutic Equivalents
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