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Gregory Glass

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Gregory Glass
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gregoryglass

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@gregoryglass

active 38 minutes ago
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    Product: Metformin Extended-release Tablets
    Company: Various
    Petition Filer: Harmen Finochem
    Petition Number(s): 2020P-1701
    Date of Petition: July 27, 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: T…[Read more]

    Profile picture of gregoryglass 2 weeks, 2 days ago

    Product: Nipride RTU®(sodium nitroprusside) Injection
    Company: Exela Pharma
    Petition Filer: Cardinal Health
    Petition Number(s): 2020P-1678
    Date of Petition: July 20, 2020
    Responding Petitions:

    Action Requested by Petitioner: Petitioner is requesting FDA to determine whether Nipriode RTU®(sodium nitroprusside) Injection 10mg/50mL (…[Read more]

    Profile picture of gregoryglass 3 weeks, 2 days ago

    Product: Dobutrex®(dobutamine) Injection
    Company: Eli Lilly
    Petition Filer: Cardinal Health
    Petition Number(s): 2020P-1650
    Date of Petition: July 10, 2020
    Responding Petitions:

    Action Requested by Petitioner: The petitioner would like to FDA to determine whether Dobutrex®(dobutamine) Injection 12.5mg base/mL (NDA 017820) was r…[Read more]

    Profile picture of gregoryglass 1 month ago
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