Regulatory Open Forum

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  • 1.  ANDA and RLD

    Posted 02-Dec-2022 10:20
    Hello Colleagues,

    Can an ANDA reference more than 1 RLD?

    Thank you.

    David Lucking

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    David Lucking
    Coral Gables FL
    United States
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  • 2.  RE: ANDA and RLD

    This message was posted by a user wishing to remain anonymous
    Posted 02-Dec-2022 10:37
    This message was posted by a user wishing to remain anonymous

    The RLD used for your bio study is logically the appropriate one for ANDA. Its different for 505b2 NDA where you can use multiple RLDs.
    Original Message


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