The formal submission to the FDA asking for permission to sell a drug — requires years of clinical trial data proving safety and efficacy.Comprehensive submission including Phase I–III clinical data, manufacturing specifications, proposed labeling, and risk management plans. FDA review typically takes 6–12 months for standard applications. Approval grants the right to market for the specific approved indication only. A successful NDA means the FDA concluded the benefit outweighs the risk for a defined patient population — not that the compound is safe for any use or population.