Visitor Monitoring Drug History: BREATHTEK UBT FOR H-PYLORI
 
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Label and Approval History

Drug Name: BREATHTEK UBT FOR H-PYLORI
FDA Application No: (NDA) 020586
Active Ingredient(s): UREA, C-13
Company: OTSUKA AMERICA
 
Label History
 
View the label approved on April 25, 2003 for BREATHTEK UBT FOR HPYLORI, (NDA) 020586


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
5/10/2001 004New Dosage Regimen Letter
Label
Review 
5/13/1999 003Control Supplement  
3/13/1998 002Labeling Revision  
4/23/1997 001Expiration Date Change  
9/17/1996 000Approval  
 
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