FDA.reportPublic FDA data

Application 211024

Type
ANDA
Sponsor
PRINSTON PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VORTIOXETINEVORTIOXETINETABLET;ORAL5MGNoNo
002VORTIOXETINEVORTIOXETINETABLET;ORAL10MGNoNo
003VORTIOXETINEVORTIOXETINETABLET;ORAL15MGNoNo
004VORTIOXETINEVORTIOXETINETABLET;ORAL20MGNoNo

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 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrintellixVORTIOXETINEREMEDYREPACK INC.239215eb-be32-4286-9677-1e5556c6cccf2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VORTIOXETINE
TrintellixVORTIOXETINEREMEDYREPACK INC.bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e2026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VORTIOXETINE
TrintellixVORTIOXETINECardinal Health 107, LLCcb1e9df4-dd74-4073-9d78-bb55593dd0002026-02-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VORTIOXETINE
TrintellixVORTIOXETINETakeda Pharmaceuticals America, Inc.1a5b68e2-14d0-419d-9ec6-1ca97145e8382025-03-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: VORTIOXETINE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71963ORIG2022-08-30