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GDUFA for ANDAs approved by CBER?

  • 1.  GDUFA for ANDAs approved by CBER?

    Posted 08-Aug-2016 12:15

    Hi,

    Does GUDFA apply to ANDAs submitted to CBER?

    For example, a product like this:

    HESPAN 6% (Hetastarch) in 0.9% Sodium Chloride. HESPAN® is a hetastarch indicated for treatment of hypovolemia when plasma volume expansion is desired.

    Thanks

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    Cynthia Katsempris
    Director, Regulatory Affairs
    Three Bridges NJ
    United States
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