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    FDA RISPERDAL NDA 020588 Approval Package — Reviews & Approval Records

    FDA RISPERDAL NDA 020588 Approval Package — Reviews & Approval Records

    $589.00 USD
    $589.00 USD
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    This FOIAdocs regulatory document collection brings together FDA approval records for RISPERDAL, NDA 020588. The package contains 53 FDA documents totaling 2,489 pages, organized by original application and supplemental submission.

    Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

    What's included

    • Original FDA approval records
    • 28 supplemental submissions represented
    • 5 FDA review documents
    • 27 approval letters
    • 21 labeling documents
    • FOIAdocs document index and detailed manifest

    Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

    Application: NDA 020588
    Product: RISPERDAL
    Sponsor: JANSSEN PHARMS
    Documents: 53
    Pages: 2,489
    Coverage: Original approval + 28 supplemental submissions represented
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