Application 208159

Type: NDA
Sponsor: WELLSTAT THERAP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VISTOGARD	URIDINE TRIACETATE	GRANULE;ORAL	10GM/PACKET	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N208159-001	VISTOGARD	URIDINE TRIACETATE	10GM/PACKET	GRANULE / ORAL		RLD, RS	2015-12-11

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208159-001	7776838	2027-08-17	U-1791		2015-12-16

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 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL	RLD, RS	2015-12-11	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208159-001	6258795	2023-07-10		Drug product	2015-12-16	`ea99ee380514…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208159-001	ODE-104	2022-12-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208159-001	ODE-104	2022-12-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208159-001	ODE-104	2022-12-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208159-001	NCE	2020-09-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N208159-001	ODE-104	2022-12-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208159-001	ODE-104	2022-12-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208159-001	ODE-104	2022-12-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208159-001	ODE-104	2022-12-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208159-001	ODE-104	2022-12-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208159-001	NCE	2020-09-04	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N208159-001	ODE-104	2022-12-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208159-001	NCE	2020-09-04	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N208159-001	ODE-104	2022-12-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208159-001	NCE	2020-09-04	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N208159-001	ODE-104	2022-12-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208159-001	NCE	2020-09-04	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N208159-001	ODE-104	2022-12-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208159-001	NCE	2020-09-04	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N208159-001	ODE-104	2022-12-11	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208159-001	ODE-104	2022-12-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208159-001	ODE-104	2022-12-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208159-001	ODE-104	2022-12-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208159-001	ODE-104	2022-12-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208159-001	ODE-104	2022-12-11	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VISTOGARD	URIDINE TRIACETATE	BTG International Inc	269f7363-63ed-444e-85f1-f0009e44818b	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208159 application number: NDA208159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69468-151	VISTOGARD	uridine triacetate	Wellstat Therapeutics Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
46068	ORIG	2016-09-30
40620	SUPPL	2016-03-31
10646	SUPPL	2016-03-31
10645	ORIG	2015-12-14
40619	ORIG	2015-12-11