Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 207318

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NUPLAZID (PIMAVANSERIN TARTRATE)
EQ 10MG BASE
Marketing Status: Prescription

Active Ingredient: PIMAVANSERIN TARTRATE
Proprietary Name: NUPLAZID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 10MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N207318
Product Number: 002
Approval Date: Jun 28, 2018
Applicant Holder Full Name: ACADIA PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

NUPLAZID (PIMAVANSERIN TARTRATE)
EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: PIMAVANSERIN TARTRATE
Proprietary Name: NUPLAZID
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 17MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N207318
Product Number: 001
Approval Date: Apr 29, 2016
Applicant Holder Full Name: ACADIA PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information