Application 020586

Type: NDA
Sponsor: OTSUKA AMERICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MERETEK UBT KIT (W/ PRANACTIN)	UREA C-13	FOR SOLUTION;ORAL	125MG/VIAL	No	No
002	BREATHTEK UBT FOR H-PYLORI	UREA C-13	FOR SOLUTION;ORAL	EQ 75MG/POUCH	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	UREA C-13	125MG/VIAL	FOR SOLUTION / ORAL			1996-09-17
N020586-002	BREATHTEK UBT FOR H-PYLORI	UREA C-13	EQ 75MG/POUCH	FOR SOLUTION / ORAL			2001-05-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020586-001	MERETEK UBT KIT (W/ PRANACTIN)	125MG/VIAL	FOR SOLUTION / ORAL	1996-09-17	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020586-002	BREATHTEK UBT FOR H-PYLORI	EQ 75MG/POUCH	FOR SOLUTION / ORAL	2001-05-10	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41448	SUPPL	2004-07-15
2783	SUPPL	2003-07-24
34885	SUPPL	2003-04-25