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gregoryglass

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@gregoryglass

Active 10 months, 1 week ago
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    Astepro Allergy®(azelastine) Nasal Spray
    Annual Sales
    Company BAYER
    Date of First Filing July 12, 2021

    Special Notes: This is an OTC product. FDA reported that both the Astepro Allergy and Children’s Astepro Allergy received their respective filings on July 12, 2021. These products share the same NDA number. The case below does not…Read more

    Profile picture of parryashford 3 days, 14 hours ago

    The Paragraph Four Report®
    Paragraph IV Activity for September 2021

    New Certifications as reported by FDA on September 7 and 21, 2021

    1. Tivicay PD®(dolutegravir) Tablets for Suspension 5 mg on 7/21/2021
    2. Nayzilam®(midazolam) Nasal Spray 5 mg/spray on 6/1/2021
    3. Invega Trinza®(paliperidone) Extended-release Injectable Suspension 273…Read more

    Profile picture of parryashford 2 weeks, 1 day ago

    Eucrisa®(crisaborole) Topical Ointment
    Annual Sales
    Company ANACOR
    Date of First Filing June 14, 2021

    Paragraph IV Applicant: Alkem
    Case Name: ANACOR PHARMACEUTICALS INC et al v. ALKEM LABORATORIES LTD
    Court/Case #: Delaware District Court (dedc) 1:2021cv01348
    Date Filed: 9/24/21
    Judge:
    Product Strength: 2%
    Litigated Patents…Read more

    Profile picture of parryashford 2 weeks, 4 days ago
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