Application 207988

Type: NDA
Sponsor: IRONWOOD PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZURAMPIC	LESINURAD	TABLET;ORAL	200MG	Yes	No

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

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
N207988-001	ZURAMPIC	LESINURAD	200MG	TABLET / ORAL		RLD	2015-12-22

Orange Book patents#

Current patent rows page 1 of 1 · 11 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207988-001	10183012	2028-11-26	U-2311		2019-02-21
N207988-001	8283369	2028-11-26	U-1802		2016-01-15
N207988-001	8283369	2028-11-26	U-1804		2016-01-15
N207988-001	8546437	2029-04-29	U-1803		2016-01-15
N207988-001	8084483	2029-08-17	U-1801		2016-01-15
N207988-001	8357713	2029-12-22	U-1801	Drug product	2016-01-15
N207988-001	8357713	2029-12-22	U-1802	Drug product	2016-01-15
N207988-001	8357713	2029-12-22	U-1803	Drug product	2016-01-15
N207988-001	9216179	2031-08-01	U-1806		2016-01-15
N207988-001	9956205	2031-12-28	U-2311		2018-05-30
N207988-001	8546436	2032-02-29		Drug substance, Drug product	2016-01-15

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 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N207988-001	ZURAMPIC	200MG	TABLET / ORAL	RLD	2015-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N207988-001	ZURAMPIC	200MG	TABLET / ORAL	RLD	2015-12-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N207988-001	ZURAMPIC	200MG	TABLET / ORAL	RLD	2015-12-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N207988-001	ZURAMPIC	200MG	TABLET / ORAL	RLD	2015-12-22	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 523 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N207988-001	10183012	2028-11-26	U-2311		2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8283369	2028-11-26	U-1804		2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8283369	2028-11-26	U-1802		2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8546437	2029-04-29	U-1803		2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8084483	2029-08-17	U-1801		2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8357713	2029-12-22	U-1801	Drug product	2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8357713	2029-12-22	U-1803	Drug product	2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8357713	2029-12-22	U-1802	Drug product	2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	9216179	2031-08-01	U-1806		2016-01-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	9956205	2031-12-28	U-2311		2018-05-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N207988-001	8546436	2032-02-29		Drug substance, Drug product	2016-01-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N207988-001	10183012	2028-11-26	U-2311		2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8283369	2028-11-26	U-1804		2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8283369	2028-11-26	U-1802		2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8546437	2029-04-29	U-1803		2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8084483	2029-08-17	U-1801		2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8357713	2029-12-22	U-1801	Drug product	2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8357713	2029-12-22	U-1803	Drug product	2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8357713	2029-12-22	U-1802	Drug product	2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	9216179	2031-08-01	U-1806		2016-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	9956205	2031-12-28	U-2311		2018-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207988-001	8546436	2032-02-29		Drug substance, Drug product	2016-01-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207988-001	10183012	2028-11-26	U-2311		2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8283369	2028-11-26	U-1804		2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8283369	2028-11-26	U-1802		2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8546437	2029-04-29	U-1803		2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8084483	2029-08-17	U-1801		2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8357713	2029-12-22	U-1801	Drug product	2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8357713	2029-12-22	U-1803	Drug product	2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8357713	2029-12-22	U-1802	Drug product	2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	9216179	2031-08-01	U-1806		2016-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	9956205	2031-12-28	U-2311		2018-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207988-001	8546436	2032-02-29		Drug substance, Drug product	2016-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207988-001	10183012	2028-11-26	U-2311		2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8283369	2028-11-26	U-1804		2016-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8283369	2028-11-26	U-1802		2016-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8546437	2029-04-29	U-1803		2016-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8084483	2029-08-17	U-1801		2016-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8357713	2029-12-22	U-1801	Drug product	2016-01-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207988-001	8357713	2029-12-22	U-1803	Drug product	2016-01-15	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207988-001	NCE	2020-12-22	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207988-001	NCE	2020-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207988-001	NCE	2020-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207988-001	NCE	2020-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207988-001	NCE	2020-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207988-001	NCE	2020-12-22	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0310-1475	ZURAMPIC	lesinurad	AstraZeneca Pharmaceutica	NDA	Current
70785-011	Zurampic	lesinurad	Ironwood Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47259	ORIG	2017-02-17
43541	ORIG	2016-02-02
24530	ORIG	2016-02-02
40608	ORIG	2015-12-23
32874	ORIG	2015-12-23