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Doc which was sent via email from June Germain on January 3 2012. OPDP s comments on the proposed IFU are based on the susbstantially complete version of the IFU titled NDA 22572 Kit Dec 6 2011. Regulatory Review Officer Division of Professional Promotion DPP Subject NDA 22572 MitosolTM for solution As requested in your consult dated August 24 2011 the Office of Prescription Drug Promotion OPDP has reviewed the proposed draft labeling for Mitosol TM for solution. 21 CFR 314. 50 i 3 Statement...
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