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Fda.gov/AboutFDA/CentersOffices/CDER/ucm090142. htm. REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA 21 CFR 314. Pdf. Reference ID 3673436 Page 2 The SPL will be accessible via publicly available labeling repositories. CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for APPLICATION NUMBER 203255Orig1s000 Trade Name Signifor LAR Generic Name Pasireotide Sponsor Novartis Pharmaceuticals Corporation Approval Date December 15 2014...

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203255orig1s000 - fda is a form used by the FDA to report specific information related to a certain product or process.

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