Application 206940

Type: NDA
Sponsor: ALLERGAN HOLDINGS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIBERZI	ELUXADOLINE	TABLET;ORAL	75MG	Yes	No
002	VIBERZI	ELUXADOLINE	TABLET;ORAL	100MG	Yes	Yes

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

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
N206940-001	VIBERZI	ELUXADOLINE	75MG	TABLET / ORAL		RLD	2015-05-27
N206940-002	VIBERZI	ELUXADOLINE	100MG	TABLET / ORAL		RLD, RS	2015-05-27

Orange Book patents#

Current patent rows page 1 of 1 · 28 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N206940-001	8691860	2028-07-07	U-1709	Drug substance	2015-06-26
N206940-001	9115091	2028-07-07	U-1738	Drug substance, Drug product	2015-09-23
N206940-001	9364489	2028-07-07	U-1709		2016-07-14
N206940-001	9789125	2028-07-07	U-1709	Drug product	2017-11-01
N206940-001	9789125	2028-07-07	U-2152	Drug product	2017-11-01
N206940-001	7741356	2029-05-27		Drug substance, Drug product	2015-06-26
N206940-001	10188632	2033-03-14		Drug product	2019-02-28
N206940-001	11007179	2033-03-14		Drug product	2021-06-03
N206940-001	11090291	2033-03-14		Drug product	2021-09-07
N206940-001	11160792	2033-03-14		Drug product	2021-11-24
N206940-001	11229627	2033-03-14		Drug product	2022-02-15
N206940-001	11311516	2033-03-14		Drug product	2022-05-19
N206940-001	12097187	2033-03-14	U-3475		2024-10-21
N206940-001	9675587	2033-03-14		Drug product	2017-08-07
N206940-002	8691860	2028-07-07	U-1709	Drug substance	2015-06-26
N206940-002	9115091	2028-07-07	U-1738	Drug substance, Drug product	2015-09-23
N206940-002	9364489	2028-07-07	U-1709		2016-07-14
N206940-002	9789125	2028-07-07	U-1709	Drug product	2017-11-01
N206940-002	9789125	2028-07-07	U-2152	Drug product	2017-11-01
N206940-002	7741356	2029-05-27		Drug substance, Drug product	2015-06-26
N206940-002	10188632	2033-03-14		Drug product	2019-02-28
N206940-002	11007179	2033-03-14		Drug product	2021-06-03
N206940-002	11090291	2033-03-14		Drug product	2021-09-07
N206940-002	11160792	2033-03-14		Drug product	2021-11-24
N206940-002	11229627	2033-03-14		Drug product	2022-02-15
N206940-002	11311516	2033-03-14		Drug product	2022-05-19
N206940-002	11484527	2033-03-14	U-3475		2022-11-22
N206940-002	9675587	2033-03-14		Drug product	2017-08-07

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206940-001	VIBERZI	75MG	TABLET / ORAL	AB	RLD	2015-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206940-002	VIBERZI	100MG	TABLET / ORAL	AB	RLD, RS	2015-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206940-001	VIBERZI	75MG	TABLET / ORAL		RLD	2015-05-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206940-002	VIBERZI	100MG	TABLET / ORAL		RLD, RS	2015-05-27	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N206940-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206940-002	AB	1	`6a471c1ec25d…`

Observed Orange Book patent history#

Patent history page 1 of 39 · 1,553 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	N206940-001	8691860	2028-07-07	U-1709	Drug substance	2015-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	9115091	2028-07-07	U-1738	Drug substance, Drug product	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	9364489	2028-07-07	U-1709		2016-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	9789125	2028-07-07	U-2152	Drug product	2017-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	9789125	2028-07-07	U-1709	Drug product	2017-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	7741356	2029-05-27		Drug substance, Drug product	2015-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	10188632	2033-03-14		Drug product	2019-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	11007179	2033-03-14		Drug product	2021-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	11090291	2033-03-14		Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	11160792	2033-03-14		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	11229627	2033-03-14		Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	11311516	2033-03-14		Drug product	2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	12097187	2033-03-14	U-3475		2024-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-001	9675587	2033-03-14		Drug product	2017-08-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	8691860	2028-07-07	U-1709	Drug substance	2015-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	9115091	2028-07-07	U-1738	Drug substance, Drug product	2015-09-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	9364489	2028-07-07	U-1709		2016-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	9789125	2028-07-07	U-1709	Drug product	2017-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	9789125	2028-07-07	U-2152	Drug product	2017-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	7741356	2029-05-27		Drug substance, Drug product	2015-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	10188632	2033-03-14		Drug product	2019-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11007179	2033-03-14		Drug product	2021-06-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11090291	2033-03-14		Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11160792	2033-03-14		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11229627	2033-03-14		Drug product	2022-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11311516	2033-03-14		Drug product	2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	11484527	2033-03-14	U-3475		2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206940-002	9675587	2033-03-14		Drug product	2017-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	10213415	2025-03-14	U-2152	Drug substance	2019-03-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	7786158	2025-03-14		Drug substance	2015-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	8344011	2025-03-14	U-1709		2015-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	8609709	2025-03-14		Drug substance	2015-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	8772325	2025-03-14	U-1709		2017-02-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9205076	2025-03-14	U-1709		2015-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9700542	2025-03-14		Drug product	2017-08-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	8691860	2028-07-07	U-1709	Drug substance	2015-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9115091	2028-07-07	U-1738	Drug substance, Drug product	2015-09-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9364489	2028-07-07	U-1709		2016-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9789125	2028-07-07	U-2152	Drug product	2017-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206940-001	9789125	2028-07-07	U-1709	Drug product	2017-11-01	`31067a03dcf5…`

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	N206940-001	NCE	2020-05-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206940-002	NCE	2020-05-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N206940-001	NCE	2020-05-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N206940-002	NCE	2020-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206940-001	NCE	2020-05-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N206940-002	NCE	2020-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206940-001	NCE	2020-05-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206940-002	NCE	2020-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206940-001	NCE	2020-05-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206940-002	NCE	2020-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206940-001	NCE	2020-05-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206940-002	NCE	2020-05-27	`ea99ee380514…`

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
Viberzi	ELUXADOLINE	Allergan, Inc.	7821bd40-4c84-4984-951b-6436ae20421a	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206940 application number: NDA206940 ndc (product): 61874-075 ndc (product): 61874-100

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-075	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current
61874-100	Viberzi	Eluxadoline	Allergan, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63640	SUPPL	2020-06-19
63623	SUPPL	2020-06-19
63622	SUPPL	2020-06-19
59104	ORIG	2019-06-17
54854	SUPPL	2018-07-06
54719	SUPPL	2018-06-28
53700	SUPPL	2018-04-16
53683	SUPPL	2018-04-16
50408	SUPPL	2017-11-14
50366	SUPPL	2017-11-13
48092	SUPPL	2017-04-24
48081	SUPPL	2017-04-21
40575	SUPPL	2017-02-14
32836	SUPPL	2016-02-12
44953	ORIG	2015-07-02
23028	ORIG	2015-07-02
40574	ORIG	2015-05-29
32835	ORIG	2015-05-28