Home Applications 020586 Application 020586
Type NDA
Sponsor OTSUKA AMERICA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MERETEK UBT KIT (W/ PRANACTIN) UREA C-13 FOR SOLUTION;ORAL 125MG/VIAL No No 002 BREATHTEK UBT FOR H-PYLORI UREA C-13 FOR SOLUTION;ORAL EQ 75MG/POUCH No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020586-001 MERETEK UBT KIT (W/ PRANACTIN) UREA C-13 125MG/VIAL FOR SOLUTION / ORAL 1996-09-17 N020586-002 BREATHTEK UBT FOR H-PYLORI UREA C-13 EQ 75MG/POUCH FOR SOLUTION / ORAL 2001-05-10
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 3 of 3 · 88 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020586-001 MERETEK UBT KIT (W/ PRANACTIN) 125MG/VIAL FOR SOLUTION / ORAL 1996-09-17 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N020586-002 BREATHTEK UBT FOR H-PYLORI EQ 75MG/POUCH FOR SOLUTION / ORAL 2001-05-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020586-001 MERETEK UBT KIT (W/ PRANACTIN) 125MG/VIAL FOR SOLUTION / ORAL 1996-09-17 e64feba35796…2022-09-29 23:25 UTC 2022-09 N020586-002 BREATHTEK UBT FOR H-PYLORI EQ 75MG/POUCH FOR SOLUTION / ORAL 2001-05-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020586-001 MERETEK UBT KIT (W/ PRANACTIN) 125MG/VIAL FOR SOLUTION / ORAL 1996-09-17 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020586-002 BREATHTEK UBT FOR H-PYLORI EQ 75MG/POUCH FOR SOLUTION / ORAL 2001-05-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020586-001 MERETEK UBT KIT (W/ PRANACTIN) 125MG/VIAL FOR SOLUTION / ORAL 1996-09-17 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020586-002 BREATHTEK UBT FOR H-PYLORI EQ 75MG/POUCH FOR SOLUTION / ORAL 2001-05-10 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 41448 SUPPL 2004-07-15 2783 SUPPL 2003-07-24 34885 SUPPL 2003-04-25