Application 210793

Type: NDA
Sponsor: ACADIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUPLAZID	PIMAVANSERIN TARTRATE	CAPSULE;ORAL	EQ 34MG BASE	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N210793-001	NUPLAZID	PIMAVANSERIN TARTRATE	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210793-001	7659285	2026-08-24	U-1844		2018-07-25
N210793-001	7732615	2028-06-03		Drug substance, Drug product	2018-07-25
N210793-001	7732615*PED	2028-12-03		Pediatric extension
N210793-001	7601740	2030-04-29		Drug substance, Drug product	2018-07-25
N210793-001	7601740*PED	2030-10-29		Pediatric extension
N210793-001	10449185	2038-08-27		Drug product	2019-11-01
N210793-001	10646480	2038-08-27		Drug product	2020-05-15
N210793-001	10849891	2038-08-27	U-1974	Drug product	2020-12-11
N210793-001	11452721	2038-08-27		Drug product	2022-09-27
N210793-001	10449185*PED	2039-02-27		Pediatric extension
N210793-001	10646480*PED	2039-02-27		Pediatric extension
N210793-001	10849891*PED	2039-02-27		Pediatric extension
N210793-001	11452721*PED	2039-02-27		Pediatric extension

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N210793-001	M-14	2029-04-27
N210793-001	PED	2029-10-27

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 · 43 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
2026-09-14 22:38:34	2026-08	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL	AB	RLD, RS	2018-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL	AB	RLD, RS	2018-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL	AB	RLD, RS	2018-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL	AB	RLD, RS	2018-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL	AB	RLD, RS	2018-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210793-001	NUPLAZID	EQ 34MG BASE	CAPSULE / ORAL		RLD, RS	2018-06-28	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210793-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210793-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210793-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210793-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210793-001	AB	1	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 537 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N210793-001	7659285	2026-08-24	U-1844		2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	7732615*PED	2028-12-03		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	7601740*PED	2030-10-29		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10449185	2038-08-27		Drug product	2019-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10646480	2038-08-27		Drug product	2020-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10849891	2038-08-27	U-1974	Drug product	2020-12-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	11452721	2038-08-27		Drug product	2022-09-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10449185*PED	2039-02-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10646480*PED	2039-02-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	10849891*PED	2039-02-27		Pediatric extension		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	11452721*PED	2039-02-27		Pediatric extension		`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210793-001	7659285	2026-08-24	U-1844		2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	7732615*PED	2028-12-03		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	7601740*PED	2030-10-29		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10449185	2038-08-27		Drug product	2019-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10646480	2038-08-27		Drug product	2020-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10849891	2038-08-27	U-1974	Drug product	2020-12-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	11452721	2038-08-27		Drug product	2022-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10449185*PED	2039-02-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10646480*PED	2039-02-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	10849891*PED	2039-02-27		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	11452721*PED	2039-02-27		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210793-001	7659285	2026-08-24	U-1844		2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	10449185	2038-08-27		Drug product	2019-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	10646480	2038-08-27		Drug product	2020-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	10849891	2038-08-27	U-1974	Drug product	2020-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210793-001	11452721	2038-08-27		Drug product	2022-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	7923564	2025-09-26		Drug substance, Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	7659285	2026-08-24	U-1844		2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	7732615	2028-06-03		Drug substance, Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	7601740	2030-04-29		Drug substance, Drug product	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	10449185	2038-08-27		Drug product	2019-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	10646480	2038-08-27		Drug product	2020-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210793-001	10849891	2038-08-27	U-1974	Drug product	2020-12-11	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N210793-001	M-14	2029-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210793-001	PED	2029-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210793-001	M-14	2029-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210793-001	PED	2029-10-27	`caaa826d4ba7…`
2019-12-13 00:20 UTC	2019-12	N210793-001	NCE	2021-04-29	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210793-001	NCE	2021-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210793-001	NCE	2021-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210793-001	NCE	2021-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210793-001	NCE	2021-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210793-001	NCE	2021-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210793-001	NCE	2021-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210793-001	NCE	2021-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210793-001	NCE	2021-04-29	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210793-001	M-14	2029-04-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N210793-001	PED	2029-10-27	`a50c72e98297…`

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
NUPLAZID	PIMAVANSERIN TARTRATE	Acadia Pharmaceuticals Inc.	1e6bea44-57d6-4bac-9328-46e1ee59f83b	2026-06-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 210793 application number: NDA210793 ndc (product): 63090-340

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals In	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals Inc	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals Inc	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals Inc	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	Acadia Pharmaceuticals Inc.	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals Inc	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	Acadia Pharmaceuticals Inc.	NDA	Current
63090-340	NUPLAZID	pimavanserin tartrate	ACADIA Pharmaceuticals Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85800	SUPPL	2026-05-01
85786	SUPPL	2026-05-01
81149	SUPPL	2025-02-07
80932	SUPPL	2025-02-05
75506	SUPPL	2023-09-18
75505	SUPPL	2023-09-18
65876	SUPPL	2021-01-11
65343	SUPPL	2020-11-25
60202	SUPPL	2019-10-02
60187	SUPPL	2019-10-01
58677	SUPPL	2019-05-14
58655	SUPPL	2019-05-13
58347	ORIG	2019-04-18
57918	SUPPL	2019-03-07
57890	SUPPL	2019-03-05
55383	ORIG	2018-09-05
54825	ORIG	2018-07-06