205777Orig1s000 - Food and Drug Administration · The ONDQA Biopharmaceutics team has reviewed NDA 205-777 for filing purposes. We found this NDA fileablefrom a Biopharmaceutics perspective.
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CENTER FOR DRUG EVALUATION AND RESEARCH...CLINICAL FILING CHECKLIST FOR NDA/BLA or Supplement File name: 5_Clinical Filing Checklist for NDA_BLA or Supplement 010908 1 NDA/BLA Number: