Application 207318

Type
NDA
Sponsor
ACADIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUPLAZIDPIMAVANSERIN TARTRATETABLET;ORALEQ 17MG BASEYesNo
002NUPLAZIDPIMAVANSERIN TARTRATETABLET;ORALEQ 10MG BASEYesYes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N207318-001NUPLAZIDPIMAVANSERIN TARTRATEEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-29
N207318-002NUPLAZIDPIMAVANSERIN TARTRATEEQ 10MG BASETABLET / ORALRLD, RS2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N207318-00176592852026-08-24U-18442016-05-25
N207318-00177326152028-06-03Drug substance, Drug product2016-05-25
N207318-0017732615*PED2028-12-03Pediatric extension
N207318-00176017402030-04-29Drug substance, Drug product2016-05-25
N207318-0017601740*PED2030-10-29Pediatric extension
N207318-00276592852026-08-24U-18442018-07-25
N207318-00277326152028-06-03Drug substance, Drug product2018-07-25
N207318-0027732615*PED2028-12-03Pediatric extension
N207318-00276017402030-04-29Drug substance, Drug product2018-07-25
N207318-0027601740*PED2030-10-29Pediatric extension
N207318-002105178602037-03-23U-19742020-01-10
N207318-002109530002037-03-23U-19742021-03-30
N207318-00210517860*PED2037-09-23Pediatric extension
N207318-00210953000*PED2037-09-23Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N207318-001M-142029-04-27
N207318-001PED2029-10-27
N207318-002M-142029-04-27
N207318-002PED2029-10-27

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-2984e616aacf4f…
2026-09-14 22:38:342026-08N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-2884e616aacf4f…
2026-08-18 06:07:402026-07N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-29caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207318-001NUPLAZIDEQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2016-04-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALABRLD, RS2018-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALABRLD, RS2018-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALABRLD, RS2018-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N207318-001NUPLAZIDEQ 17MG BASETABLET / ORALRLD2016-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207318-002NUPLAZIDEQ 10MG BASETABLET / ORALRLD, RS2018-06-2874a2ff9319b5…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N207318-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N207318-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N207318-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N207318-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N207318-002AB11c564ffb4f44…

Observed Orange Book patent history#

Patent history page 1 of 21 · 839 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N207318-00176592852026-08-24U-18442016-05-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-00177326152028-06-03Drug substance, Drug product2016-05-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-0017732615*PED2028-12-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N207318-00176017402030-04-29Drug substance, Drug product2016-05-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-0017601740*PED2030-10-29Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N207318-00276592852026-08-24U-18442018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-00277326152028-06-03Drug substance, Drug product2018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-0027732615*PED2028-12-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N207318-00276017402030-04-29Drug substance, Drug product2018-07-2584e616aacf4f…
2026-09-14 22:38:342026-08N207318-0027601740*PED2030-10-29Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N207318-002105178602037-03-23U-19742020-01-1084e616aacf4f…
2026-09-14 22:38:342026-08N207318-002109530002037-03-23U-19742021-03-3084e616aacf4f…
2026-09-14 22:38:342026-08N207318-00210517860*PED2037-09-23Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N207318-00210953000*PED2037-09-23Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N207318-00176592852026-08-24U-18442016-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00177326152028-06-03Drug substance, Drug product2016-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-0017732615*PED2028-12-03Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00176017402030-04-29Drug substance, Drug product2016-05-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-0017601740*PED2030-10-29Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00276592852026-08-24U-18442018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00277326152028-06-03Drug substance, Drug product2018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-0027732615*PED2028-12-03Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00276017402030-04-29Drug substance, Drug product2018-07-25caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-0027601740*PED2030-10-29Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N207318-002105178602037-03-23U-19742020-01-10caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-002109530002037-03-23U-19742021-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00210517860*PED2037-09-23Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N207318-00210953000*PED2037-09-23Pediatric extensioncaaa826d4ba7…
2026-02-19 14:30 UTC2026-02N207318-00176592852026-08-24U-18442016-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-00177326152028-06-03Drug substance, Drug product2016-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-00176017402030-04-29Drug substance, Drug product2016-05-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-00276592852026-08-24U-18442018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-00277326152028-06-03Drug substance, Drug product2018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-00276017402030-04-29Drug substance, Drug product2018-07-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-002105178602037-03-23U-19742020-01-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N207318-002109530002037-03-23U-19742021-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-00179235642025-09-26Drug substance, Drug product2016-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-00176592852026-08-24U-18442016-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-00177326152028-06-03Drug substance, Drug product2016-05-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N207318-00176017402030-04-29Drug substance, Drug product2016-05-2531067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N207318-001M-142029-04-2784e616aacf4f…
2026-09-14 22:38:342026-08N207318-001PED2029-10-2784e616aacf4f…
2026-09-14 22:38:342026-08N207318-002M-142029-04-2784e616aacf4f…
2026-09-14 22:38:342026-08N207318-002PED2029-10-2784e616aacf4f…
2026-08-18 06:07:402026-07N207318-001M-142029-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-001PED2029-10-27caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-002M-142029-04-27caaa826d4ba7…
2026-08-18 06:07:402026-07N207318-002PED2029-10-27caaa826d4ba7…
2019-12-13 00:20 UTC2019-12N207318-001NCE2021-04-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N207318-002NCE2021-04-2974a2ff9319b5…
2021-12-28 21:50 UTC2021-12N207318-001NCE2021-04-29782e0a99824c…
2021-12-28 21:50 UTC2021-12N207318-002NCE2021-04-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207318-001NCE2021-04-2987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N207318-002NCE2021-04-2987673890dc5c…
2021-03-12 10:30 UTC2021-03N207318-001NCE2021-04-295aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N207318-002NCE2021-04-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N207318-001NCE2021-04-298869cabd3fbd…
2020-12-22 03:56 UTC2020-12N207318-002NCE2021-04-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N207318-001NCE2021-04-29c0c555d07b60…
2020-11-12 02:37 UTC2020-11N207318-002NCE2021-04-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12N207318-001NCE2021-04-293f01610625f2…
2019-12-14 00:12 UTC2019-12N207318-002NCE2021-04-293f01610625f2…
2019-09-15 20:21 UTC2019-09N207318-001NCE2021-04-29b00525d2431f…
2019-09-15 20:21 UTC2019-09N207318-002NCE2021-04-29b00525d2431f…
2019-07-19 19:46 UTC2019-07N207318-001NCE2021-04-29ea99ee380514…
2019-07-19 19:46 UTC2019-07N207318-002NCE2021-04-29ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207318-001M-142029-04-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207318-001PED2029-10-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207318-002M-142029-04-27a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N207318-002PED2029-10-27a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUPLAZIDPIMAVANSERIN TARTRATEAcadia Pharmaceuticals Inc.1e6bea44-57d6-4bac-9328-46e1ee59f83b2026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 207318
application number: NDA207318
ndc (product): 63090-100

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 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals InNDACurrent
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-100NUPLAZIDpimavanserin tartrateAcadia Pharmaceuticals Inc.NDACurrent
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-100NUPLAZIDpimavanserin tartrateAcadia Pharmaceuticals Inc.NDACurrent
63090-100NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals InNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-170NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85839SUPPL 2026-05-05
85785SUPPL 2026-05-01
80931SUPPL 2026-05-01
81148SUPPL 2025-02-07
75507SUPPL 2023-09-18
75504SUPPL 2023-09-18
65342SUPPL2020-11-25
65321SUPPL2020-11-25
60201SUPPL2019-10-02
60169SUPPL2019-10-01
58675SUPPL2019-05-14
58654SUPPL2019-05-13
57917SUPPL2019-03-07
57889SUPPL2019-03-05
55384SUPPL2018-09-05
54826SUPPL2018-07-06
54552SUPPL2018-06-14
54486SUPPL2018-06-08
53015SUPPL2018-03-15
53014SUPPL2018-03-15
52824SUPPL2018-03-06
52823SUPPL2018-03-06
50152SUPPL2017-10-23
50106SUPPL2017-10-19
44957ORIG2016-06-02
23034ORIG2016-06-02
40585ORIG2016-05-02
10614ORIG2016-05-02