Content of a product's approved labeling-essential chemistry, pharmacology, toxicology, indications and contraindication for use. adverse effects formulation composition, dosage, and storage requirements. Treatment IND, Orphan drug Supplemental new drug application (SNDA) Abbreviated new drug application(简化新药申请)to gain approved to market a duplicate Antibiotic drug: biologics: Medical devicesContent of a product’s approved labeling-essential chemistry, pharmacology, toxicology, indications and contraindication for use, adverse effects, formulation composition, dosage, and storage requirements. Treatment IND, Orphan drug Supplemental new drug application (SNDA) Abbreviated new drug application(简化新药申请) to gain approved to market a duplicate Antibiotic drug; biologics; Medical devices