RE: RE: RE: how could I find related information about ANDA review process? Contribution from Vamshi written on 8/31/2010 at 15:32
Original contribution: RE: RE: how could I find related information about ANDA review process? written by ok on 8/31/2010 at 02:34)
Dear Ok,
If there is ANDA under review by FDA, you cannot know its progress of review by any means. If its your ANDA then you can contact FDA and ask them about the ANDA progress.
But if it is an ANDA by 3rd party, FDA keeps that information confidential and you cannot know about it. However, once the ANDA is approved you can find the Summary basis of approval (FOI), in the FDA website.
Another important thing is, in case of Paragrapph IV filing, FDA maintains a database of recently submitted ANDAs sponsors on its website.
Hope this answers your question.
regards,
Vamshi
RA-Associate
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