CLINICAL FILING CHECKLIST FOR A NEW NDA/BLA
Application Type NDA Submission Number 202-022 (SDN 000) Submission Code Type 1 (NME) Letter Date July 23, 2010 Stamp Date July 23, 2010 PDUFA Goal Date May 23, 2010 Reviewer Name Yodit Belew Review Completion Date March 28, 2010 Established Name Rilpivirine (TMC278) (Proposed) Trade Name Therapeutic Class NNRTI Applicant Tibotec ................
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