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Re: zipjet post# 54410

Tuesday, 11/06/2007 4:34:19 PM

Tuesday, November 06, 2007 4:34:19 PM

Post# of 257257
>MNTA – another interesting take-away from the CC was that there is no "approvable letter" issued in ANDA's. So while the FDA response is in the form of a "not approvable letter" the requests for additional information on immunogenicity is similar to requests received in "approvable letters"<

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