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Gregory Glass

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Gregory Glass
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gregoryglass

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@gregoryglass

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    Product: Dicloxacillin Sodium Capsules
    Company: Teva and Sandoz
    Petition Filer: Aurobindo
    Petition Number(s): 2020P-1427
    Date of Petition: May 28, 2020
    Responding Petitions:

    Issue and Implication: Whether FDA can designate a second Reference Standard when the current RS is in limited supply.

    Action Requested by Petitioner: The…[Read more]

    Profile picture of gregoryglass 6 days, 3 hours ago

    Product: Impoyz®(clobetasol) Topical Cream
    Company: Encore Dermatology
    Petition Filer: Encore Dermatology
    Petition Number(s): 2020P-1421
    Date of Petition: May 27, 2020
    Responding Petitions:

    Issue and Implication: Whether an ANDA product must have identical ingredients to achieve bioequivalency and safety and efficacy.

    Action…[Read more]

    Profile picture of gregoryglass 1 week ago

    Product: Vibramycin®(doxycycline) Injection
    Company: Pfizer/Fresenius Kabi
    Petition Filer: Hymen Phelps
    Petition Number(s): 2020P-1403
    Date of Petition: May 20, 2020
    Responding Petitions:

    Issue and Implication: Whether an ANDA can serve as a Reference List Drug when it contains a non-exception excipient.

    Action Requested by…[Read more]

    Profile picture of gregoryglass 2 weeks ago
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