Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020586
Company: OTSUKA AMERICA

Products on NDA 20586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BREATHTEK UBT FOR H-PYLORI	UREA C-13	EQ 75MG/POUCH	FOR SOLUTION;ORAL	Discontinued	None	No	No
MERETEK UBT KIT (W/ PRANACTIN)	UREA C-13	125MG/VIAL	FOR SOLUTION;ORAL	Discontinued	None	No	No

Labels for NDA 020586

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/10/2001	SUPPL-4	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf