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 2 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
2019-12-13 00:20 UTC	2019-12	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209203-001	DUZALLO	200MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209203-002	DUZALLO	300MG;200MG	TABLET / ORAL	RLD	2017-08-18	`3a93d1ddd44b…`

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