Drugs@FDA: FDA-Approved Drugs

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

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

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