Application 021897

Type: NDA
Sponsor: ALKERMES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIVITROL	NALTREXONE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	380MG/VIAL	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N021897-001	VIVITROL	NALTREXONE	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021897-001	7919499	2029-10-15	U-1123		2011-05-16
N021897-001	7919499	2029-10-15	U-1124		2011-05-16

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 · 42 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
2026-08-18 06:07:40	2026-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2006-04-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021897-001	VIVITROL	380MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2006-04-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2023-12-20 04:57 UTC	2023-12	N021897-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021897-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021897-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021897-001	AP	1	`a67488948f0b…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1124		2011-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021897-001	7919499	2029-10-15	U-1123		2011-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6331317	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6395304	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6495166	2019-11-12		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021897-001	6537586	2019-11-12		Drug product		`74a2ff9319b5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VIVITROL	NALTREXONE	Alkermes, Inc.	cd11c435-b0f0-4bb9-ae78-60f101f3703f	2026-05-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021897 application number: NDA021897 ndc (product): 65757-300 ndc (product): 65757-301
Naltrexone	NALTREXONE	Amneal Pharmaceuticals NY LLC	6de5637f-d527-4228-af1a-3aae71155cb5	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021897 application number: NDA021897

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-300	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-301	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current
65757-301	VIVITROL	naltrexone	Alkermes, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84687	SUPPL	2026-01-06
84603	SUPPL	2025-12-31
72224	SUPPL	2022-10-03
67444	SUPPL	2021-05-10
66597	SUPPL	2021-03-08
66596	SUPPL	2021-03-08
66553	SUPPL	2021-03-05
62896	SUPPL	2020-05-11
62884	SUPPL	2020-05-11
59948	SUPPL	2019-09-09
59947	SUPPL	2019-09-09
59938	SUPPL	2019-09-09
57102	SUPPL	2019-01-02
57056	SUPPL	2018-12-30
6412	SUPPL	2016-05-19
44485	SUPPL	2015-12-29
6411	SUPPL	2015-12-29
37844	SUPPL	2015-12-10
37843	SUPPL	2014-06-12
37842	SUPPL	2014-06-12
6410	SUPPL	2013-07-31
6409	SUPPL	2013-07-31
37841	SUPPL	2010-10-13
28806	SUPPL	2010-10-13
24012	ORIG	2010-10-13
16538	SUPPL	2010-03-26
16537	SUPPL	2010-03-26
6408	SUPPL	2010-03-25
6407	SUPPL	2010-03-25
44159	ORIG	2008-08-12
21863	ORIG	2008-01-16
28805	SUPPL	2007-11-08
16536	SUPPL	2007-11-07
6406	ORIG	2006-04-21
37840	ORIG	2006-04-14