Application 211759

Type: NDA
Sponsor: CARWIN PHARM ASSOC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VYSCOXA	CELECOXIB	SUSPENSION;ORAL	10MG/ML	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
N211759-001	VYSCOXA	CELECOXIB	10MG/ML	SUSPENSION / ORAL		RLD, RS	2025-07-29

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
N211759-001	12678405	2045-09-17		Drug product	2026-08-12

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211759-001	VYSCOXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211759-001	VYSCOXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211759-001	VYSCOXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211759-001	VYSCOXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-07-29	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211759-001	VYSCOXA	10MG/ML	SUSPENSION / ORAL	RLD, RS	2025-07-29	`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
2026-08-18 06:07:40	2026-07	N211759-001	12678405	2045-09-17		Drug product	2026-08-12	`caaa826d4ba7…`

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
VYSCOXA	CELECOXIB	Carwin Pharmaceutical Associates, LLC	5094d47e-f791-4190-9397-b7500143a74d	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211759 application number: NDA211759

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84905	ORIG	2026-02-03
82996	ORIG	2025-07-31
82993	ORIG	2025-07-30
82992	ORIG	2025-07-30