Application 209203

Type: NDA
Sponsor: IRONWOOD PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DUZALLO	ALLOPURINOL; LESINURAD	TABLET;ORAL	200MG;200MG	Yes	No
002	DUZALLO	ALLOPURINOL; LESINURAD	TABLET;ORAL	300MG;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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N209203-001	DUZALLO	ALLOPURINOL; LESINURAD	200MG;200MG	TABLET / ORAL		RLD	2017-08-18
N209203-002	DUZALLO	ALLOPURINOL; LESINURAD	300MG;200MG	TABLET / ORAL		RLD	2017-08-18

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209203-001	10183012	2028-11-26	U-2104		2019-02-21
N209203-001	8283369	2028-11-26	U-2104		2017-09-15
N209203-001	8546437	2029-04-29	U-2104		2017-09-15
N209203-001	8084483	2029-08-17	U-2104		2017-09-15
N209203-001	8357713	2029-12-22	U-2104	Drug product	2017-09-15
N209203-001	9216179	2031-08-01	U-2104		2017-09-15
N209203-001	9956205	2031-12-28	U-2104		2018-05-30
N209203-001	8546436	2032-02-29		Drug substance	2017-09-15
N209203-002	10183012	2028-11-26	U-2104		2019-02-21
N209203-002	8283369	2028-11-26	U-2104		2017-09-15
N209203-002	8546437	2029-04-29	U-2104		2017-09-15
N209203-002	8084483	2029-08-17	U-2104		2017-09-15
N209203-002	8357713	2029-12-22	U-2104	Drug product	2017-09-15
N209203-002	9216179	2031-08-01	U-2104		2017-09-15
N209203-002	9956205	2031-12-28	U-2104		2018-05-30
N209203-002	8546436	2032-02-29		Drug substance	2017-09-15

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 3 of 3 · 88 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	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 782 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	N209203-001	10183012	2028-11-26	U-2104		2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	8283369	2028-11-26	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	8546437	2029-04-29	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	8084483	2029-08-17	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	8357713	2029-12-22	U-2104	Drug product	2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	9216179	2031-08-01	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	9956205	2031-12-28	U-2104		2018-05-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-001	8546436	2032-02-29		Drug substance	2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	10183012	2028-11-26	U-2104		2019-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	8283369	2028-11-26	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	8546437	2029-04-29	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	8084483	2029-08-17	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	8357713	2029-12-22	U-2104	Drug product	2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	9216179	2031-08-01	U-2104		2017-09-15	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	9956205	2031-12-28	U-2104		2018-05-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209203-002	8546436	2032-02-29		Drug substance	2017-09-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209203-001	10183012	2028-11-26	U-2104		2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	8283369	2028-11-26	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	8546437	2029-04-29	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	8084483	2029-08-17	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	8357713	2029-12-22	U-2104	Drug product	2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	9216179	2031-08-01	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	9956205	2031-12-28	U-2104		2018-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-001	8546436	2032-02-29		Drug substance	2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	10183012	2028-11-26	U-2104		2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	8283369	2028-11-26	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	8546437	2029-04-29	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	8084483	2029-08-17	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	8357713	2029-12-22	U-2104	Drug product	2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	9216179	2031-08-01	U-2104		2017-09-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	9956205	2031-12-28	U-2104		2018-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209203-002	8546436	2032-02-29		Drug substance	2017-09-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209203-001	10183012	2028-11-26	U-2104		2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	8283369	2028-11-26	U-2104		2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	8546437	2029-04-29	U-2104		2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	8084483	2029-08-17	U-2104		2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	8357713	2029-12-22	U-2104	Drug product	2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	9216179	2031-08-01	U-2104		2017-09-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	9956205	2031-12-28	U-2104		2018-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209203-001	8546436	2032-02-29		Drug substance	2017-09-15	`caaa826d4ba7…`

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
70785-021	Duzallo	lesinurad and allopurinol	Ironwood Pharmaceuticals, Inc.	NDA	Current
70785-022	Duzallo	lesinurad and allopurinol	Ironwood Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
53643	ORIG	2018-04-10
49506	ORIG	2017-08-22
49499	ORIG	2017-08-22
49498	ORIG	2017-08-22