Visitor Monitoring Drug Details: BREATHTEK UBT FOR H-PYLORI
 
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Drug Details

Drug Name: BREATHTEK UBT FOR H-PYLORI
FDA Application No: (NDA) 020586
Active Ingredient(s): UREA, C-13
Company: OTSUKA AMERICA
Original Approval or Tentative Approval Date: September 17, 1996
Chemical Type: 1 New molecular entity (NME)
Review Classification: S Standard review drug
 
There are no Therapeutic Equivalents Label Information
Approval History, Letters, Reviews and Related Documents
 
You can see the products in the same application. The table can be sorted by clicking the header columns.
 
Drug NameSort imageActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE Code
BREATHTEK UBT FOR H-PYLORI UREA, C-13EQ 75MG /POUCHFOR SOLUTION; ORAL Prescription Yes None
MERETEK UBT KIT (W/ PRANACTIN) UREA, C-13125MG/VIALFOR SOLUTION; ORAL Discontinued No None


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