FDA.reportPublic FDA data

Application 210793

Type
NDA
Sponsor
ACADIA PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NUPLAZIDPIMAVANSERIN TARTRATECAPSULE;ORALEQ 34MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals InNDACurrent
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-340NUPLAZIDpimavanserin tartrateAcadia Pharmaceuticals Inc.NDACurrent
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent
63090-340NUPLAZIDpimavanserin tartrateAcadia Pharmaceuticals Inc.NDACurrent
63090-340NUPLAZIDpimavanserin tartrateACADIA Pharmaceuticals IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85800SUPPL 2026-05-01
85786SUPPL 2026-05-01
81149SUPPL 2025-02-07
80932SUPPL 2025-02-05
75506SUPPL 2023-09-18
75505SUPPL 2023-09-18
65876SUPPL2021-01-11
65343SUPPL2020-11-25
60202SUPPL2019-10-02
60187SUPPL2019-10-01
58677SUPPL2019-05-14
58655SUPPL2019-05-13
58347ORIG2019-04-18
57918SUPPL2019-03-07
57890SUPPL2019-03-05
55383ORIG2018-09-05
54825ORIG2018-07-06