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parryashford

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@parryashford

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    Nymalize®(nimodipine) Oral Solution
    Annual Sales
    Company ARBOR
    Date of First Filing November 29, 2021

    Paragraph IV Applicant: Alkem
    Case Name: ARBOR PHARMACEUTICALS LLC v. ALKEM LABORATORIES LTD
    Court/Case #: New Jersey District Court (njdc) 1:2022cv00143
    Date Filed: 1/11/22
    Judge: Williams
    Product Strength: 6 mg/mL
    Litigated…Read more

    Profile picture of parryashford 2 days, 17 hours ago

    The Paragraph Four Report®
    Paragraph IV Activity for December 2021

    New Certifications as reported by FDA on December 13 and 28, 2021

    1. Calquence®(acalabrutini) Capsules 100 mg on 11/1/2021
    2. Nymalize®(nimodipine) Oral Solution 6 mg/mL on 11/29/2021
    3. Antizol®(fomepizole) Injection 1.5g/1.5mL on 11/1/2021

    Comments: The December lis…Read more

    Profile picture of parryashford 2 weeks, 1 day ago

    Onureg®(azacitidine) Tablets
    Annual Sales $17M (as reported by Bristol Myers)
    Company CELGENE
    Date of First Filing September 30, 2021

    Paragraph IV Applicant: Accord
    Case Name: CELGENE CORPORATION et al v. ACCORD HEALTHCARE INC
    Court/Case #: Delaware District Court (dedc) 1:2021cv01795
    Date Filed: 12/22/21
    Judge: Andrews
    Prod…Read more

    Profile picture of parryashford 3 weeks, 2 days ago
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