Visitor Monitoring Drug History: TRANDATE
 
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Label and Approval History

Drug Name: TRANDATE
FDA Application No: (NDA) 019425
Active Ingredient(s): LABETALOL HYDROCHLORIDE
Company: PROMETHEUS LABS
 
Label History
 
Labels are not available on this site for TRANDATE, (NDA) 019425
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
12/18/2002 020Manufacturing Change or Addition  
8/13/1998 019Labeling Revision  
5/1/1997 017Manufacturing Change or Addition  
4/20/1994 016Labeling Revision  
5/27/1993 015Labeling Revision  
6/5/1991 013Labeling Revision  
2/1/1991 012Labeling Revision  
6/7/1990 011Labeling Revision  
11/7/1990 009Labeling Revision  
3/23/1990 008Control Supplement  
10/19/1989 007Labeling Revision  
10/19/1989 006Labeling Revision  
11/16/1987 005Control Supplement  
11/13/1987 004Manufacturing Change or Addition  
9/22/1987 003Labeling Revision  
5/22/1987 002Package Change  
11/13/1986 001Labeling Revision  
12/31/1985 000Approval  
 
Therapeutic Equivalents
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