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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N208159-001	VISTOGARD	10GM/PACKET	GRANULE / ORAL		RLD, RS	2015-12-11	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N208159-001	7776838	2027-08-17	U-1791		2015-12-16	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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