orange book

Orange Book. Patents. A list of patents on drugs or drug products for which generic-drug applications may be submitted to the Food and Drug Administration. • The expiration dates of the patents are also listed. An applicant may submit a generic-drug application at any time, but the applicant must either accept deferral of FDA approval until the patent expires or contest the patent’s validity. The Orange Book’s official title is Approved Drug Products with Therapeutic Equivalence Evaluations.
专业法律词汇 词条贡献者
译员黎川,在一家顶尖澳洲律师事务所的上海办公室担任全职法律翻译,专注翻译各种与澳大利亚业务有关的法律文件。
Scroll to Top