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Last Updated: December 14, 2025

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

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

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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	4,830,010	⤷ Get Started Free
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996	5,140,993	⤷ Get Started Free
Otsuka America	MERETEK UBT KIT (W/ PRANACTIN)	urea c-13	FOR SOLUTION;ORAL	020586-001	Sep 17, 1996	4,830,010	⤷ Get Started Free
Otsuka America	BREATHTEK UBT FOR H-PYLORI	urea c-13	FOR SOLUTION;ORAL	020586-002	May 10, 2001	5,140,993	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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