Drugs@FDA: FDA-Approved Drugs

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

Products on NDA 020586

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/17/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Supplements

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) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20586s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20586-S004%20AP%20ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-586s004_Pranactin.cfm
05/13/1999	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
03/13/1998	SUPPL-2	Labeling		Label is not available on this site.
04/23/1997	SUPPL-1	Manufacturing (CMC)-Expiration Date		Label is not available on this site.

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