Visitor Monitoring Drug History: HELIDAC
 
Drugs Directory of False Positives DRUGS THAT CAUSES A FALSE POSITIVE ON A DRUG TEST
 
Browse by Letter: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9
Label and Approval History

Drug Name: HELIDAC
FDA Application No: (NDA) 050719
Active Ingredient(s): BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
Company: PROMETHEUS LABS
 
Label History
 
View the label approved on September 15, 2004 for HELIDAC, (NDA) 050719


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
7/24/2007 009Labeling Revision Letter 
9/10/2004 008Labeling Revision Letter
Label 
4/27/2003 007Labeling Revision Letter
Label 
12/12/2002 006Labeling Revision Letter
Label 
6/30/1999 005Labeling Revision  
7/29/1999 004Manufacturing Change or Addition  
10/30/1998 003Manufacturing Change or Addition  
5/15/1998 002Control Supplement  
8/28/1997 001Labeling Revision  
8/15/1996 000Approval Letter 
 
There are no Therapeutic Equivalents
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