Visitor Monitoring Drug History: NORMODYNE
 
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Label and Approval History

Drug Name: NORMODYNE
FDA Application No: (NDA) 018687
Active Ingredient(s): LABETALOL HYDROCHLORIDE
Company: SCHERING
 
Label History
 
Labels are not available on this site for NORMODYNE, (NDA) 018687
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/22/2000 023Manufacturing Change or Addition  
10/27/2000 022Manufacturing Change or Addition  
4/25/2000 021Labeling Revision  
1/27/2000 020Manufacturing Change or Addition  
5/28/1993 019Control Supplement  
1/27/1993 018Package Change  
9/16/1991 017Control Supplement  
10/15/1992 016Labeling Revision  
11/7/1990 015Labeling Revision  
6/16/1989 014Labeling Revision  
11/22/1988 013Control Supplement  
6/16/1989 012Labeling Revision  
2/23/1989 011Manufacturing Change or Addition  
4/14/1988 010Labeling Revision  
2/5/1987 009Manufacturing Change or Addition  
8/31/1987 008Labeling Revision  
8/8/1986 007Control Supplement  
1/14/1986 006Control Supplement  
8/31/1987 005Labeling Revision  
6/28/1985 003Control Supplement  
8/31/1987 002Labeling Revision  
8/1/1984 000Approval  
 
Therapeutic Equivalents
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