系列6：标签Labeling
仿制药与创新药具有相同的活性成分、剂型、给药途径和治疗作用，能降低医疗支出、提高药品可及性等。标签是仿制药ANDA申请的一部分，本部分收录了FDA仿制药标签相关的指南。
6.1_Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn
6.1_参比制剂上市许可撤消后，更新ANDA标签
发布日期：07/11/2016
目前状态：草案
This guidance describes a process for updating labeling for abbreviated new drug applications (ANDAs) in cases where FDA has withdrawn approval of the new drug application (NDA) for the ANDA’s reference listed drug (RLD) for reasons other than safety or effectiveness. Where approval of the NDA for the RLD has been withdrawn by FDA under these circumstances (referred to in this guidance as a “withdrawn RLD”), and ANDAs are pending or generic drugs continue to be marketed under one or more ANDAs that rely on the withdrawn RLD, the labeling of those pending or marketed ANDA products may need to be updated to reflect changes that would have been necessary had the NDA for the RLD not been withdrawn.
在FDA出于安全性或有效性以外的其他原因，撤回了对ANDA参比制剂(RLD)的情况下，本指南介绍了在对ANDA进行标签更新的流程。在这种情况下，FDA撤销了针对RLD的NDA批准(在本指南中称为“撤销的RLD”)，而此时ANDA正在申请之中，或者仿制药继续在一种或多种依赖于RLD的ANDA下进行销售。如果撤回了RLD，则可能需要更新那些待上市或已上市的ANDA产品的标签，以反映出相应的变更。
6.2_Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval
6.2_标签草案的可接受性以支持ANDA批准：问答指南
发布日期：10/07/2015
目前状态：草案
This guidance provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs) under section 505(j)(2)(A)(v) of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s implementing regulations (21 CFR 314.94(a)(8)).
基于联邦食品、药品和化妆品法第505(j)(2)(A)(v)条和FDA的实施法规(21 CFR 314.94(a)(8))，提出了ANDA建议标签，对此本指南提供了相关的建议和信息。
This guidance is intended to assist applicants submitting ANDAs under section 505(j) of the Act to the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). It explains FDA’s interpretation of the regulatory provision related to the submission of copies of applicants’ proposed labeling in ANDAs and clarifies that OGD will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA.
本指南旨在帮助申请人，根据该法第505(j)节向药品评估研究中心(CDER)的仿制药办公室(OGD)提交ANDA。就与在ANDA中提交申请人提议的标签副本有关的法规规定，本指南说明了FDA的解释，并阐明OGD将接受标签草案，并且不需要提交最终印刷标签(FPL)即可批准ANDA。
6.3_Revising ANDA Labeling Following Revision of the RLD Labeling
6.3_修正RLD标签后修正ANDA标签
发布日期：04/26/2000
目前状态：定稿
During the marketing life of a drug product approved under a new drug application (NDA), the package insert labeling is frequently revised. When an NDA serves as an RLD for an ANDA, approved changes in the RLD labeling generally necessitate changes in the labeling of one or more ANDAs using the RLD. Under the Federal Food, Drug, and Cosmetic Act and Agency regulations, an ANDA product must have the same labeling as the RLD.
基于NDA批准的药品，在上市期间，包装说明书标签经常被修改。当NDA用作ANDA的RLD时，批准的RLD标签更改，通常需要更改使用RLD的一个或多个ANDA的标签。根据联邦食品、药品和化妆品法和FDA的规定，ANDA产品必须具有与RLD相同的标签。
