Visitor Monitoring Drug History: PEPCID PRESERVATIVE FREE
 
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 PRESERVATIVE FREE
FDA Application No: (NDA) 019510
Active Ingredient(s): FAMOTIDINE
Company: MERCK
 
Label History
 
View the label approved on March 14, 2001 for PEPCID PRESERVATIVE FREE, (NDA) 019510


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
8/1/2002 030Package Change  
3/14/2001 029Labeling Revision Letter
Label 
6/6/2002 028Efficacy Supplement with Clinical Data to Support Letter
Label 
4/25/2001 027Labeling Revision  
3/18/1999 026Labeling Revision Review 
1/28/1999 025Labeling Revision  
12/19/1997 024Control Supplement  
11/12/1997 023Labeling Revision  
5/16/1997 022Labeling Revision  
5/6/1999 021Control Supplement  
8/12/1998 020Labeling Revision  
1/30/1996 019Package Change  
6/29/1995 018Labeling Revision  
6/29/1995 017Labeling Revision  
6/29/1995 016Labeling Revision  
5/8/1996 015Package Change  
11/30/1990 012Labeling Revision  
5/16/1997 011Labeling Revision  
12/10/1991 010Labeling Revision  
6/29/1995 009Labeling Revision  
11/30/1990 008Labeling Revision  
11/30/1990 007Labeling Revision  
10/28/1988 006Labeling Revision  
1/7/1992 005Manufacturing Change or Addition  
11/23/1988 004Labeling Revision  
6/3/1987 003Control Supplement  
4/1/1987 002Labeling Revision  
12/12/1986 001Labeling Revision  
11/4/1986 000Approval Label 
 
Therapeutic Equivalents
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