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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. CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for APPLICATION NUMBER 206995Orig1s000 Trade Name Generic Name Sponsor AstraZeneca UK Limited Approval Date July 13 2015 Indications is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer NSCLC whose tumors have epidermal...
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