Visitor Monitoring Drug History: PEPCID AC
 
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: PEPCID AC
FDA Application No: (NDA) 020325
Active Ingredient(s): FAMOTIDINE
Company: MERCK
 
Label History
 
View the label approved on September 30, 2003 for PEPCID AC, (NDA) 020325


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
6/9/2006 019Labeling Revision Letter 
10/27/2004 017Labeling Revision Letter 
9/23/2003 015New Dosage Regimen Letter
Label
Review 
3/1/2002 013Labeling Revision Letter 
4/5/2000 011Package Change  
2/10/2000 010Manufacturing Change or Addition  
11/5/1998 009Control Supplement  
4/15/1998 008Package Change  
11/9/1998 007New Dosage Regimen  
9/26/1997 006Package Change  
4/23/1996 004Manufacturing Change or Addition  
5/3/1996 003Package Change Letter 
10/2/1995 002Manufacturing Change or Addition  
5/31/1996 001Control Supplement  
4/28/1995 000Approval  
 
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