FDA.reportPublic FDA data

Application 214750

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PIMAVANSERINPIMAVANSERINUNKNOWNUNKNOWNNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pimavanserinPIMAVANSERINNovadoz Pharmaceuticals LLC403b6540-c53d-4e92-91b4-36ca6338b2b12023-11-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: pimavanserin
generic name: PIMAVANSERIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67436ORIG2021-05-07