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MATERIAL REVIEWED Draft HFA furoate Metered Dose Inhaler PPI and IFU received on June 27 2013 and received by DMPP on March 11 2014. furoate is the active ingredient in the Sponsor s approved products Twisthaler NDA 21067 and NDA 22518. 04/22/2014 ANTHONY G DURMOWICZ PMR/PMC Development Template This template should be completed by the PMR/PMC Development Coordinator and included for each PMR/PMC in the Action Package. Regulatory Project Manager CC Kathleen Klemm Pharm.D. Group Leader OPDP...

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