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Gregory Glass

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Gregory Glass
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gregoryglass

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@gregoryglass

active 2 hours, 19 minutes ago
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    Product: Zovirax®(acyclovir) Capsules
    Company: Mylan
    Petition Filer: Yiling Pharmaceutical
    Petition Number(s): 2020P-1072
    Date of Petition: March 12, 2020
    Responding Petitions: None

    Action Requested by Petitioner: The Petitioner asks FDA to determine whether acyclovir capsules 200 mg (NDA 018828) was withdrawn for reasons of safety…[Read more]

    Profile picture of gregoryglass 2 weeks, 2 days ago

    Product: B. Braun Medical Injectable Products
    Company: B. Braun Medical
    Petition Filer: B. Braun Medical
    Petition Number(s): 2020P-1065
    Date of Petition: March 12, 2020
    Responding Petitions:

    Issue and Implication: Whether certain 505(b)(2) products merit “A” therapeutic equivalence ratings.

    Action Requested by Petitioner: Petitio…[Read more]

    Profile picture of gregoryglass 2 weeks, 2 days ago

    Product: Tenex®(guanfacine) Tablets
    Company: Promius Pharma
    Petition Filer: Unichem
    Petition Number(s): 2020P-0813
    Date of Petition: March 12, 2020
    Responding Petitions: None

    Action Requested by Petitioner: The Petitioner asks FDA to determine whether Tenex®(guanfacine) Tablets 1 and 2 mg (NDA 019032) was withdrawn for reasons of s…[Read more]

    Profile picture of gregoryglass 2 weeks, 2 days ago
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