BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Rejoyn

    Reg #: 3010447004 · FEI: 3010447004 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Otsuka Pharmaceutical Development & Commercialization, Inc
    Registration Number
    3010447004
    FEI Number
    3010447004
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    508 Carnegie Center
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231209

    Owner / Operator

    Firm Name
    OTSUKA AMERICA PHARMACEUTICAL INC
    Operator Number
    9107159
    Address
    2440 RESEARCH BLVD., --
    City
    Rockville
    State
    MD
    Postal Code
    20850
    Country
    US
    Correspondent
    Michael Fahmy

    Products

    Device Name Product Code
    Computerized Behavioral Therapy Device For Depressive Disorders. SAP

    Proprietary Names

    Rejoyn

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility