Orange Book product · Brand (NDA)
BREATHTEK UBT FOR H-PYLORI
UREA C-13
Brand (NDA)NDA 020586DISCN OTSUKA AMERICA
At a glance
May 10, 2001
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 10, 2001
25 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
UREA C-13
Strength
EQ 75MG/POUCH
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 020586
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
