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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:205834Orig1s000 ADMINISTRATIVE and CORRESPONDENCE DOCUMENTSEXCLUSIVITY SUMMARY NDA # 205834SUPPL #HAD #Trade Name HARMONY Generic Name ledipasvir/sofosbuvir
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The GAO-20-244 FDA drug approval is a process through which the Food and Drug Administration (FDA) reviews and approves new drugs for market availability.
Drug companies seeking to bring new medications to market are required to file for GAO-20-244 FDA drug approval.
To fill out GAO-20-244 FDA drug approval, drug companies need to submit detailed information on the safety, efficacy, and manufacturing of the new drug.
The purpose of GAO-20-244 FDA drug approval is to ensure that new drugs meet safety and efficacy standards before being sold to the public.
Information such as clinical trial data, drug composition, manufacturing processes, and proposed labeling must be reported on GAO-20-244 FDA drug approval.
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