Visitor Monitoring Drug History: TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
 
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Label and Approval History

Drug Name: TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
FDA Application No: (NDA) 019434
Active Ingredient(s): CIMETIDINE HYDROCHLORIDE
Company: GLAXOSMITHKLINE
 
Label History
 
Labels are not available on this site for TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9 IN PLASTIC CONTAINER, (NDA) 019434
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
1/8/1998 030Manufacturing Change or Addition  
4/15/1997 029Control Supplement  
12/6/1994 028Manufacturing Change or Addition  
2/22/1995 027Labeling Revision  
11/10/1993 026Manufacturing Change or Addition  
9/13/1993 025Manufacturing Change or Addition  
6/8/1993 024Manufacturing Change or Addition  
10/23/1996 022Package Change  
6/4/1992 021Control Supplement  
7/16/1992 020Control Supplement  
1/7/1992 019Labeling Revision  
8/27/1992 018Control Supplement  
1/30/1992 016Control Supplement  
5/23/1991 015Control Supplement  
11/13/1991 014Labeling Revision  
11/13/1989 013Labeling Revision  
5/30/1990 011Control Supplement  
3/7/1991 010Labeling Revision  
6/26/1989 009Labeling Revision  
3/20/1989 008Manufacturing Change or Addition  
6/26/1989 007Labeling Revision  
6/15/1988 005Labeling Revision  
5/20/1988 004Labeling Revision  
3/31/1988 003New Dosage Regimen  
4/29/1986 002Labeling Revision  
4/23/1986 001Labeling Revision  
10/31/1985 000Approval  
 
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