FDA NDA · NDA020586

MERETEK UBT KIT (W/ PRANACTIN)

Sponsor: OTSUKA AMERICA

APPLICATION

NDA020586

TYPE

NDA

ORIGINAL APPROVAL

1996-09-17

LATEST ACTION

2001-05-10

ROUTE

ORAL

DOSAGE FORM

FOR SOLUTION

MARKETING STATUS

Discontinued

Products

MERETEK UBT KIT (W/ PRANACTIN)Discontinued

UREA C-13 125MG/VIAL · FOR SOLUTION · ORAL

BREATHTEK UBT FOR H-PYLORIDiscontinued

UREA C-13 EQ 75MG/POUCH · FOR SOLUTION · ORAL

2001-05-10Efficacy · Supplement 4 · standard — Review ↗AP

1999-05-13Manufacturing (CMC) · Supplement 3 · standardAP

1998-03-13Labeling · Supplement 2 · standardAP

1997-04-23Manufacturing (CMC) · Supplement 1 · standardAP

1996-09-17Type 1 - New Molecular Entity · Original · standardAP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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