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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-two drug master file entries for this compound. Additional details are available on the urea c-13 profile page.

Summary for NDA: 020586

Tradename:
BREATHTEK UBT FOR H-PYLORI
Applicant:
Otsuka America
Ingredient:
urea c-13
Patents:0
Formulation / Manufacturing:see details

Summary for product number 001

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

Summary for product number 002

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

Expired Orange Book 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;ORAL020586-002May 10, 20014,830,010► subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 19965,140,993► subscribe
Otsuka America
MERETEK UBT KIT (W/ PRANACTIN)
urea c-13
FOR SOLUTION;ORAL020586-001Sep 17, 19964,830,010► subscribe
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