Application 021964

Type: NDA
Sponsor: SALIX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RELISTOR	METHYLNALTREXONE BROMIDE	SOLUTION;SUBCUTANEOUS	12MG/0.6ML (12MG/0.6ML)	Yes	Yes
002	RELISTOR	METHYLNALTREXONE BROMIDE	SOLUTION;SUBCUTANEOUS	8MG/0.4ML (8MG/0.4ML)	Yes	Yes
003	RELISTOR	METHYLNALTREXONE BROMIDE	SOLUTION;SUBCUTANEOUS	12MG/0.6ML (12MG/0.6ML)	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
N021964-001	RELISTOR	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2008-04-24
N021964-002	RELISTOR	METHYLNALTREXONE BROMIDE	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2010-09-27
N021964-003	RELISTOR	METHYLNALTREXONE BROMIDE	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2010-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021964-001	12303592	2027-08-03	U-4197	Drug product	2025-06-12
N021964-001	12303592	2027-08-03	U-4198	Drug product	2025-06-12
N021964-001	8420663	2029-09-30	U-1185		2013-04-24
N021964-001	8822490	2029-09-30	U-1185	Drug product	2014-09-22
N021964-001	9180125	2029-09-30	U-1185	Drug product	2015-11-20
N021964-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30
N021964-001	8247425	2030-12-31	U-1185		2012-09-13
N021964-002	12303592	2027-08-03	U-4197	Drug product	2025-06-12
N021964-002	12303592	2027-08-03	U-4198	Drug product	2025-06-12
N021964-002	8420663	2029-09-30	U-1185
N021964-002	8822490	2029-09-30	U-1185	Drug product	2014-09-22
N021964-002	9180125	2029-09-30	U-1185	Drug product	2015-11-20
N021964-002	9492445	2029-09-30	U-1185	Drug product	2017-08-30
N021964-002	8247425	2030-12-31	U-1185
N021964-003	12303592	2027-08-03	U-4197	Drug product	2025-06-12
N021964-003	12303592	2027-08-03	U-4198	Drug product	2025-06-12
N021964-003	8420663	2029-09-30	U-1185
N021964-003	8822490	2029-09-30	U-1185	Drug product	2014-09-22
N021964-003	9180125	2029-09-30	U-1185	Drug product	2015-11-20
N021964-003	9492445	2029-09-30	U-1185	Drug product	2017-08-30
N021964-003	8247425	2030-12-31	U-1185

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS	AP	RLD, RS	2010-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021964-002	RELISTOR	8MG/0.4ML (8MG/0.4ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021964-003	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2010-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021964-001	RELISTOR	12MG/0.6ML (12MG/0.6ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2008-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021964-002	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021964-003	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021964-002	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021964-003	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021964-002	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021964-003	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021964-002	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021964-003	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021964-002	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021964-003	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021964-002	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021964-003	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021964-002	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021964-003	AP	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 24 · 951 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	N021964-001	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	8420663	2029-09-30	U-1185		2013-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-001	8247425	2030-12-31	U-1185		2012-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	8420663	2029-09-30	U-1185			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-002	8247425	2030-12-31	U-1185			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	8420663	2029-09-30	U-1185			`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	9492445	2029-09-30	U-1185	Drug product	2017-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021964-003	8247425	2030-12-31	U-1185			`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	8420663	2029-09-30	U-1185		2013-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-001	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	N021964-001	8247425	2030-12-31	U-1185		2012-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	8420663	2029-09-30	U-1185			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-002	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	N021964-002	8247425	2030-12-31	U-1185			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	12303592	2027-08-03	U-4197	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	12303592	2027-08-03	U-4198	Drug product	2025-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	8420663	2029-09-30	U-1185			`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	8822490	2029-09-30	U-1185	Drug product	2014-09-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021964-003	9180125	2029-09-30	U-1185	Drug product	2015-11-20	`31067a03dcf5…`

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): 021964 application number: NDA021964 ndc (product): 65649-551 ndc (product): 65649-552

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
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-551	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current
65649-552	Relistor	Methylnaltrexone bromide	Salix Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66357	SUPPL	2021-02-24
52979	SUPPL	2018-03-15
52966	SUPPL	2018-03-15
49562	SUPPL	2017-08-29
49222	SUPPL	2017-08-03
49219	SUPPL	2017-08-03
48459	SUPPL	2017-05-19
48437	SUPPL	2017-05-18
28932	SUPPL	2014-10-02
16648	SUPPL	2014-09-30
28933	SUPPL	2013-08-27
16649	SUPPL	2013-08-27
16647	SUPPL	2010-07-30
28931	SUPPL	2010-07-28
6548	SUPPL	2010-01-21
16646	SUPPL	2009-11-23
42362	ORIG	2008-06-03
28930	ORIG	2008-04-28