Application 200063

Type: NDA
Sponsor: NALPROPION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CONTRAVE	BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	90MG;8MG	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
N200063-001	CONTRAVE	BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2014-09-10

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200063-001	9107837	2027-06-04	U-1639		2015-09-03
N200063-001	10307376	2027-11-08	U-1585		2019-06-17
N200063-001	12048769	2027-11-08	U-1585		2024-08-19
N200063-001	8318788	2027-11-08	U-1584		2014-10-06
N200063-001	8722085	2027-11-08	U-1585		2014-10-06
N200063-001	9125868	2027-11-08	U-1585		2015-10-15
N200063-001	8088786	2029-02-03		Drug product	2014-10-06
N200063-001	11324741	2029-05-29	U-1583		2022-05-19
N200063-001	8916195	2030-02-02	U-1639		2015-01-20
N200063-001	11033543	2031-01-10	U-1583		2021-09-22
N200063-001	9248123	2032-01-13	U-1808		2016-02-17
N200063-001	10403170	2033-06-05	U-1583		2021-10-29
N200063-001	11139056	2033-06-05	U-1583		2021-10-29
N200063-001	9633575	2033-06-25	U-1583		2021-10-29
N200063-001	10231964	2034-07-02	U-1583		2019-04-17
N200063-001	10828294	2034-07-02	U-1583		2020-12-14
N200063-001	10835527	2034-07-02	U-1583		2020-12-14
N200063-001	11998542	2034-07-02	U-1583		2024-07-05

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200063-001	CONTRAVE	90MG;8MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2014-09-10	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 775 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	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8318788	2027-11-08	U-1584		2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8722085	2027-11-08	U-1585		2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9125868	2027-11-08	U-1585		2015-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8088786	2029-02-03		Drug product	2014-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11324741	2029-05-29	U-1583		2022-05-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	8916195	2030-02-02	U-1639		2015-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11033543	2031-01-10	U-1583		2021-09-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9248123	2032-01-13	U-1808		2016-02-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10403170	2033-06-05	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11139056	2033-06-05	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	9633575	2033-06-25	U-1583		2021-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10231964	2034-07-02	U-1583		2019-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10828294	2034-07-02	U-1583		2020-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	10835527	2034-07-02	U-1583		2020-12-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200063-001	11998542	2034-07-02	U-1583		2024-07-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8318788	2027-11-08	U-1584		2014-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8722085	2027-11-08	U-1585		2014-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9125868	2027-11-08	U-1585		2015-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8088786	2029-02-03		Drug product	2014-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11324741	2029-05-29	U-1583		2022-05-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	8916195	2030-02-02	U-1639		2015-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11033543	2031-01-10	U-1583		2021-09-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9248123	2032-01-13	U-1808		2016-02-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10403170	2033-06-05	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11139056	2033-06-05	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	9633575	2033-06-25	U-1583		2021-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10231964	2034-07-02	U-1583		2019-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10828294	2034-07-02	U-1583		2020-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	10835527	2034-07-02	U-1583		2020-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200063-001	11998542	2034-07-02	U-1583		2024-07-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	7375111	2025-03-26		Drug product	2014-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	9107837	2027-06-04	U-1639		2015-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	10307376	2027-11-08	U-1585		2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200063-001	12048769	2027-11-08	U-1585		2024-08-19	`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
Contrave Extended-Release	NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE	Nalpropion Pharmaceuticals LLC	485ff360-32c8-11df-928b-0002a5d5c51b	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200063 application number: NDA200063 ndc (product): 51267-890

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
43063-772	Contrave	naltrexone hydrochloride and bupropion hydrochloride	PD-Rx Pharmaceuticals, Inc.	NDA	Current
50090-2868	CONTRAVE	naltrexone hydrochloride and bupropion hydrochloride	A-S Medication Solutions	NDA	Current
50090-2945	Contrave	naltrexone hydrochloride and bupropion hydrochloride	A-S Medication Solutions	NDA	Current
50090-2945	Contrave	naltrexone hydrochloride and bupropion hydrochloride	A-S Medication Solutions	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals LLC	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals, Inc.	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals LLC	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals, Inc.	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals LLC	NDA	Current
51267-890	Contrave	naltrexone hydrochloride and bupropion hydrochloride	Nalpropion Pharmaceuticals LLC	NDA	Current
64764-890	CONTRAVE	naltrexone hydrochloride and bupropion hydrochloride	Takeda Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84103	SUPPL	2025-11-06
84102	SUPPL	2025-11-06
84101	SUPPL	2025-11-06
84090	SUPPL	2025-11-06
84089	SUPPL	2025-11-06
78439	SUPPL	2024-05-08
78416	SUPPL	2024-05-07
76712	SUPPL	2023-12-01
76710	SUPPL	2023-12-01
67089	SUPPL	2021-04-16
67088	SUPPL	2021-04-16
67087	SUPPL	2021-04-16
64204	SUPPL	2020-08-05
64203	SUPPL	2020-08-05
64198	SUPPL	2020-08-05
54665	SUPPL	2018-06-21
54664	SUPPL	2018-06-21
54605	SUPPL	2018-06-14
48291	SUPPL	2017-05-09
48253	SUPPL	2017-05-05
47555	SUPPL	2017-03-14
47531	SUPPL	2017-03-13
24382	ORIG	2014-11-12
22827	ORIG	2014-11-12
32005	ORIG	2014-09-16
40003	ORIG	2014-09-11