Details for New Drug Application (NDA): 020586
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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 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 125MG/VIAL | ||||
Approval Date: | Sep 17, 1996 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 75MG/POUCH | ||||
Approval Date: | May 10, 2001 | TE: | 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 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka America | MERETEK UBT KIT (W/ PRANACTIN) | urea c-13 | FOR SOLUTION;ORAL | 020586-001 | Sep 17, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka America | MERETEK UBT KIT (W/ PRANACTIN) | urea c-13 | FOR SOLUTION;ORAL | 020586-001 | Sep 17, 1996 | ⤷ Sign Up | ⤷ Sign Up |
Otsuka America | BREATHTEK UBT FOR H-PYLORI | urea c-13 | FOR SOLUTION;ORAL | 020586-002 | May 10, 2001 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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