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Last Updated: September 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020586

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NDA 020586 describes MERETEK UBT KIT (W/ PRANACTIN), which is a drug marketed by Otsuka America and is included in one NDA. Additional details are available on the MERETEK UBT KIT (W/ PRANACTIN) profile page.

The generic ingredient in MERETEK UBT KIT (W/ PRANACTIN) is urea c-13. There are thirty-three drug master file entries for this compound. Additional details are available on the urea c-13 profile page.
Summary for 020586
Tradename:MERETEK UBT KIT (W/ PRANACTIN)
Applicant:Otsuka America
Ingredient:urea c-13
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength125MG/VIAL
Approval Date:Sep 17, 1996TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrengthEQ 75MG/POUCH
Approval Date:May 10, 2001TE:RLD:No

Expired US Patents for NDA 020586

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001   Start Trial   Start Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996   Start Trial   Start Trial
Otsuka America MERETEK UBT KIT (W/ PRANACTIN) urea c-13 FOR SOLUTION;ORAL 020586-001 Sep 17, 1996   Start Trial   Start Trial
Otsuka America BREATHTEK UBT FOR H-PYLORI urea c-13 FOR SOLUTION;ORAL 020586-002 May 10, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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