Application 202811

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LINZESS	LINACLOTIDE	CAPSULE;ORAL	145MCG	Yes	Yes
002	LINZESS	LINACLOTIDE	CAPSULE;ORAL	290MCG	Yes	No
003	LINZESS	LINACLOTIDE	CAPSULE;ORAL	72MCG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N202811-001	LINZESS	LINACLOTIDE	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30
N202811-002	LINZESS	LINACLOTIDE	290MCG	CAPSULE / ORAL	RLD	2012-08-30
N202811-003	LINZESS	LINACLOTIDE	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202811-001	7304036	2026-08-30	U-1278	Drug substance, Drug product	2012-09-18
N202811-001	7304036	2026-08-30	U-1516	Drug substance, Drug product	2012-09-18
N202811-001	7304036	2026-08-30	U-4345	Drug substance, Drug product	2012-09-18
N202811-001	7304036*PED	2027-02-28		Pediatric extension
N202811-001	8933030	2031-02-17	U-4345	Drug product	2015-02-06
N202811-001	8933030*PED	2031-08-17		Pediatric extension
N202811-001	8748573	2031-10-30	U-1515		2014-06-11
N202811-001	8748573	2031-10-30	U-1516		2014-06-11
N202811-001	8748573	2031-10-30	U-4345		2014-06-11
N202811-001	8802628	2031-10-30		Drug product	2014-08-19
N202811-001	8748573*PED	2032-04-30		Pediatric extension
N202811-001	8802628*PED	2032-04-30		Pediatric extension
N202811-001	9708371	2033-08-16	U-1515	Drug product	2017-08-10
N202811-001	9708371	2033-08-16	U-1516	Drug product	2017-08-10
N202811-001	9708371	2033-08-16	U-4345	Drug product	2017-08-10
N202811-001	9708371*PED	2034-02-16		Pediatric extension
N202811-002	7304036	2026-08-30	U-1278	Drug substance, Drug product
N202811-002	7304036	2026-08-30	U-1516	Drug substance, Drug product
N202811-002	7304036*PED	2027-02-28		Pediatric extension
N202811-002	8933030	2031-02-17		Drug product	2015-02-06
N202811-002	8933030*PED	2031-08-17		Pediatric extension
N202811-002	8748573	2031-10-30	U-1515		2014-06-11
N202811-002	8748573	2031-10-30	U-1516		2014-06-11
N202811-002	8802628	2031-10-30		Drug product	2014-08-19
N202811-002	8748573*PED	2032-04-30		Pediatric extension
N202811-002	8802628*PED	2032-04-30		Pediatric extension
N202811-002	9708371	2033-08-16	U-1515	Drug product	2017-08-10
N202811-002	9708371*PED	2034-02-16		Pediatric extension
N202811-003	7304036	2026-08-30	U-1516	Drug substance, Drug product	2017-02-24
N202811-003	7304036	2026-08-30	U-3644	Drug substance, Drug product	2017-02-24
N202811-003	7304036*PED	2027-02-28		Pediatric extension
N202811-003	8933030	2031-02-17	U-1516	Drug product	2017-02-24
N202811-003	8933030	2031-02-17	U-3644	Drug product	2017-02-24
N202811-003	10675325	2031-08-11		Drug product	2020-06-22
N202811-003	10702576	2031-08-11	U-1516		2020-08-04
N202811-003	10702576	2031-08-11	U-3644		2020-08-04
N202811-003	8933030*PED	2031-08-17		Pediatric extension
N202811-003	10675325*PED	2032-02-11		Pediatric extension
N202811-003	10702576*PED	2032-02-11		Pediatric extension
N202811-003	9708371	2033-08-16	U-1516	Drug product	2017-08-10
N202811-003	9708371	2033-08-16	U-3644	Drug product	2017-08-10
N202811-003	9708371*PED	2034-02-16		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 5 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N202811-001	I-921	2026-06-12
N202811-001	NPP	2028-11-04
N202811-001	PED	2029-05-04
N202811-003	I-921	2026-06-12
N202811-003	NPP	2029-05-21

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 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202811-002	LINZESS	290MCG	CAPSULE / ORAL	RLD	2012-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202811-003	LINZESS	72MCG	CAPSULE / ORAL	RLD, RS	2017-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202811-001	LINZESS	145MCG	CAPSULE / ORAL	RLD, RS	2012-08-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-03-12 10:30 UTC	2021-03	N202811-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202811-002	AB	1	`5aa47cf7b7d7…`

Observed Orange Book patent history#

Patent history page 1 of 38 · 1,490 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202811-001	7304036	2026-08-30	U-1278	Drug substance, Drug product	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	7304036	2026-08-30	U-4345	Drug substance, Drug product	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	7304036	2026-08-30	U-1516	Drug substance, Drug product	2012-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	7304036*PED	2027-02-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8933030	2031-02-17	U-4345	Drug product	2015-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8933030*PED	2031-08-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8748573	2031-10-30	U-1515		2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8748573	2031-10-30	U-1516		2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8748573	2031-10-30	U-4345		2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8802628	2031-10-30		Drug product	2014-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8748573*PED	2032-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	8802628*PED	2032-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	9708371	2033-08-16	U-1515	Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	9708371	2033-08-16	U-1516	Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	9708371	2033-08-16	U-4345	Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	9708371*PED	2034-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	7304036	2026-08-30	U-1278	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	7304036	2026-08-30	U-1516	Drug substance, Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	7304036*PED	2027-02-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8933030	2031-02-17		Drug product	2015-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8933030*PED	2031-08-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8748573	2031-10-30	U-1516		2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8748573	2031-10-30	U-1515		2014-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8802628	2031-10-30		Drug product	2014-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8748573*PED	2032-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	8802628*PED	2032-04-30		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	9708371	2033-08-16	U-1515	Drug product	2017-08-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-002	9708371*PED	2034-02-16		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	7304036	2026-08-30	U-1516	Drug substance, Drug product	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	7304036	2026-08-30	U-3644	Drug substance, Drug product	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	7304036*PED	2027-02-28		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	8933030	2031-02-17	U-1516	Drug product	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	8933030	2031-02-17	U-3644	Drug product	2017-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	10675325	2031-08-11		Drug product	2020-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	10702576	2031-08-11	U-1516		2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	10702576	2031-08-11	U-3644		2020-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	8933030*PED	2031-08-17		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	10675325*PED	2032-02-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	10702576*PED	2032-02-11		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	9708371	2033-08-16	U-1516	Drug product	2017-08-10	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202811-001	I-921	2026-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	NPP	2028-11-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-001	PED	2029-05-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202811-003	I-921	2026-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202811-001	I-921	2026-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202811-003	I-921	2026-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202811-001	I-921	2026-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202811-003	I-921	2026-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202811-001	I-921	2026-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202811-003	I-921	2026-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202811-001	I-921	2026-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202811-003	I-921	2026-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202811-001	I-921	2026-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202811-003	I-921	2026-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202811-001	I-921	2026-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202811-003	I-921	2026-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202811-001	I-921	2026-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202811-003	I-921	2026-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202811-001	I-921	2026-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202811-003	I-921	2026-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202811-001	I-921	2026-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202811-003	I-921	2026-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202811-001	I-921	2026-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202811-003	I-921	2026-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202811-001	I-921	2026-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202811-003	I-921	2026-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202811-001	I-921	2026-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202811-003	I-921	2026-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202811-001	I-921	2026-06-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N202811-003	I-921	2026-06-12	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	N202811-003	NS	2020-01-25	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202811-003	NS	2020-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202811-003	NS	2020-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202811-003	NS	2020-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202811-003	NS	2020-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202811-003	NS	2020-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202811-001	I-921	2026-06-12	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202811-003	I-921	2026-06-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202811-001	I-921	2026-06-12	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N202811-003	I-921	2026-06-12	`1c564ffb4f44…`

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
Linzess	LINACLOTIDE	Allergan, Inc.	09beda19-56d6-4a56-afdc-9a77b70b2ef3	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202811 application number: NDA202811 ndc (product): 0456-1202 ndc (product): 0456-1203 ndc (product): 0456-1201

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1201	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1202	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current
0456-1203	Linzess	linaclotide	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84071	SUPPL	2025-11-05
84065	SUPPL	2025-11-05
84064	SUPPL	2025-11-05
74485	SUPPL	2023-06-13
74484	SUPPL	2023-06-13
74482	SUPPL	2023-06-13
68473	SUPPL	2021-08-26
68469	SUPPL	2021-08-26
68467	SUPPL	2021-08-26
67064	SUPPL	2021-04-15
67063	SUPPL	2021-04-15
67049	SUPPL	2021-04-13
64713	SUPPL	2020-09-29
64712	SUPPL	2020-09-29
64658	SUPPL	2020-09-23
57946	SUPPL	2019-03-11
47543	SUPPL	2017-03-14
47526	SUPPL	2017-03-13
47515	SUPPL	2017-03-09
47004	SUPPL	2017-01-27
46977	SUPPL	2017-01-25
45209	SUPPL	2016-08-31
45191	SUPPL	2016-08-31
10114	SUPPL	2016-04-08
40225	SUPPL	2016-04-07
19384	SUPPL	2015-11-25
32314	SUPPL	2015-11-24
40224	SUPPL	2014-07-11
32313	SUPPL	2014-07-10
40223	SUPPL	2013-08-12
32312	SUPPL	2013-08-12
44867	ORIG	2012-10-04
43414	ORIG	2012-10-04
32311	ORIG	2012-08-31
19383	ORIG	2012-08-31