Visitor Monitoring Drug History: TRANDATE
 
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: TRANDATE
FDA Application No: (NDA) 018716
Active Ingredient(s): LABETALOL HYDROCHLORIDE
Company: PROMETHEUS LABS
 
Label History
 
Labels are not available on this site for TRANDATE, (NDA) 018716
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
4/23/2003 023Manufacturing Change or Addition Letter 
8/13/1998 022Labeling Revision  
4/21/1997 021Manufacturing Change or Addition  
5/27/1993 020Labeling Revision  
6/5/1991 019Labeling Revision  
5/27/1993 018Labeling Revision  
2/1/1991 017Labeling Revision  
6/7/1990 016Labeling Revision  
11/7/1990 015Labeling Revision  
12/22/1989 014Manufacturing Change or Addition  
4/7/1989 013Package Change  
6/16/1989 012Labeling Revision  
6/16/1989 011Labeling Revision  
8/27/1987 010Manufacturing Change or Addition  
9/22/1987 009Labeling Revision  
11/13/1986 008Labeling Revision  
5/24/1985 006Labeling Revision  
5/24/1985 005Labeling Revision  
8/8/1985 004Package Change  
4/16/1985 002Package Change  
3/26/1985 001Formulation Revision  
8/1/1984 000Approval  
 
Therapeutic Equivalents
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