Application 208854

Type: NDA
Sponsor: BDSI

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYMPROIC	NALDEMEDINE TOSYLATE	TABLET;ORAL	EQ 0.2MG BASE	Yes	Yes

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

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
N208854-001	SYMPROIC	NALDEMEDINE TOSYLATE	EQ 0.2MG BASE	TABLET / ORAL		RLD, RS	2017-03-23

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02
N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02
N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31
N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21
N208854-001	12350377	2033-05-13		Drug product	2025-07-11

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 2 · 41 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	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208854-001	SYMPROIC	EQ 0.2MG BASE	TABLET / ORAL	RLD, RS	2017-03-23	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 160 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	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	RE46365	2031-02-24		Drug substance, Drug product	2017-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208854-001	12350377	2033-05-13		Drug product	2025-07-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	RE46365	2028-01-11		Drug substance, Drug product	2017-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	9108975	2031-11-11		Drug substance, Drug product	2017-03-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208854-001	10952968	2033-05-13		Drug substance, Drug product	2021-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208854-001	RE46375	2026-10-05	U-1185	Drug substance, Drug product	2017-05-02	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208854-001	NCE	2022-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208854-001	NCE	2022-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208854-001	NCE	2022-03-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208854-001	NCE	2022-03-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208854-001	NCE	2022-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208854-001	NCE	2022-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208854-001	NCE	2022-03-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208854-001	NCE	2022-03-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208854-001	NCE	2022-03-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208854-001	NCE	2022-03-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208854-001	NCE	2022-03-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208854-001	NCE	2022-03-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208854-001	NCE	2022-03-23	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N208854-001	NCE	2022-03-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208854-001	NCE	2022-03-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208854-001	NCE	2022-03-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208854-001	NCE	2022-03-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208854-001	NCE	2022-03-23	`cb3db0bc1861…`

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
SYMPROIC	NALDEMEDINE	BioDelivery Sciences International Inc	b1a1256c-a1eb-4abe-ab1e-30e4711afd16	2025-07-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208854 application number: NDA208854 ndc (product): 59385-041

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59011-523	Symproic	naldemedine	Purdue Pharma LP	NDA	Current
59011-523	Symproic	naldemedine	Purdue Pharma LP	NDA	Current
59385-041	SYMPROIC	naldemedine tosylate	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine tosylate	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine	BioDelivery Sciences International Inc	NDA	Current
59385-041	SYMPROIC	naldemedine	BioDelivery Sciences International Inc	NDA	Current
59630-222	SYMPROIC	naldemedine	Shionogi Inc.	NDA	Current
59630-222	SYMPROIC	naldemedine	Shionogi Inc.	NDA	Current
59630-222	SYMPROIC	naldemedine	Shionogi Inc.	NDA	Current
59630-222	SYMPROIC	naldemedine	Shionogi Inc.	NDA	Current
59630-222	SYMPROIC	naldemedine	Shionogi Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82894	SUPPL	2025-07-21
82893	SUPPL	2025-07-21
82882	SUPPL	2025-07-16
52093	SUPPL	2018-01-30
51913	SUPPL	2018-01-26
51911	SUPPL	2018-01-26
49210	SUPPL	2017-08-02
49203	SUPPL	2017-08-02
48241	ORIG	2017-05-05
47697	ORIG	2017-03-24
47669	ORIG	2017-03-24