Visitor Monitoring Drug History: ZANTAC 75
 
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Label and Approval History

Drug Name: ZANTAC 75
FDA Application No: (NDA) 020520
Active Ingredient(s): RANITIDINE HYDROCHLORIDE
Company: BOEHRINGER INGELHEIM
 
Label History
 
Labels are not available on this site for ZANTAC 75, (NDA) 020520
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
2/28/2005 015Labeling Revision Letter 
12/3/2002 013Manufacturing Change or Addition  
5/30/2002 012Manufacturing Change or Addition  
5/29/2001 010Labeling Revision  
11/8/2000 009Manufacturing Change or Addition  
6/7/2000 008Manufacturing Change or Addition  
2/28/2000 006Manufacturing Change or Addition  
4/1/1998 005Package Change  
12/8/1997 004Manufacturing Change or Addition  
5/22/1998 003Package Change  
3/26/1997 002Package Change  
6/8/1998 001New or Modified Indication Review 
12/19/1995 000Approval  
 
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