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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: NDA 21-027/S-015 Trade Name: Hector Generic Name: Doxercalciferol Sponsor: Enzyme Corporation Approval Date: 12/8/2008
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nda 21-027s-015 - govfdaaccessdatawww is a specific document or application submitted to the FDA for approval of a new drug.
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The purpose of nda 21-027s-015 - govfdaaccessdatawww is to seek FDA approval for the marketing and distribution of a new drug in the United States.
nda 21-027s-015 - govfdaaccessdatawww requires reporting of extensive information such as drug formulation, manufacturing process, clinical trial data, safety and efficacy results, proposed labeling, and any adverse events associated with the drug.
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