Visitor Monitoring Drug History: LOPERAMIDE HYDROCHLORIDE
 
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Label and Approval History

Drug Name: LOPERAMIDE HYDROCHLORIDE
FDA Application No: (ANDA) 073254
Active Ingredient(s): LOPERAMIDE HYDROCHLORIDE
Company: LEINER
 
Label History
 
Labels are not available on this site for LOPERAMIDE HYDROCHLORIDE, (ANDA) 073254
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
9/21/2000 010Facility Addition  
8/16/1999 009Control Supplement  
3/9/1998 008Labeling  
8/26/1996 007Chemistry  
2/28/1996 006Chemistry  
2/28/1996 005Labeling  
8/30/1994 004Chemistry  
7/25/1995 003Chemistry  
5/27/1994 002Chemistry  
7/30/1993 000Approval  
 
Therapeutic Equivalents
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