Application 208271

Type: NDA
Sponsor: SALIX

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RELISTOR	METHYLNALTREXONE BROMIDE	TABLET;ORAL	150MG	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
N208271-001	RELISTOR	METHYLNALTREXONE BROMIDE	150MG	TABLET / ORAL		RLD, RS	2016-07-19

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208271-001	8420663	2029-09-30	U-1185		2016-07-25
N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25
N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30
N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16
N208271-001	10307417	2031-03-10		Drug product	2019-06-07
N208271-001	10376505	2031-03-10		Drug product	2019-09-10
N208271-001	8524276	2031-03-10		Drug product	2016-07-25
N208271-001	8956651	2031-03-10		Drug product	2016-07-25
N208271-001	9314461	2031-03-10		Drug product	2016-08-12

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	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208271-001	RELISTOR	150MG	TABLET / ORAL	RLD, RS	2016-07-19	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 368 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	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	10307417	2031-03-10		Drug product	2019-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	10376505	2031-03-10		Drug product	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8524276	2031-03-10		Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	8956651	2031-03-10		Drug product	2016-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208271-001	9314461	2031-03-10		Drug product	2016-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	8420663	2029-09-30	U-1185		2016-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9180125	2029-09-30	U-1185	Drug product	2016-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208271-001	9724343	2029-09-30	U-1185	Drug product	2017-08-16	`b8a1b40f171c…`

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	N208271-001	NP	2019-07-19	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N208271-001	NP	2019-07-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208271-001	NP	2019-07-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208271-001	NP	2019-07-19	`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
Relistor	METHYLNALTREXONE BROMIDE	Salix Pharmaceuticals, Inc.	c488fb7c-0a5b-487c-b452-996809d1cb99	2024-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208271 application number: NDA208271 ndc (product): 65649-150

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-150	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66358	SUPPL	2021-02-24
52980	SUPPL	2018-03-15
52967	SUPPL	2018-03-15
50471	ORIG	2017-11-22
49563	SUPPL	2017-08-29
49221	ORIG	2017-08-03
49220	SUPPL	2017-08-03
48458	SUPPL	2017-05-19
48436	SUPPL	2017-05-18
32902	ORIG	2016-07-22
40630	ORIG	2016-07-21