仿制药申请的的评审官着重于生物等效性资料，化学和生物资料，工厂检查的要求和药品标签信息等。

Generic drug application reviewers focus on bioequivalence data, chemistry and microbiology data, requests for plant inspection, and drug labeling information.

药品标签上标明含有75微克的活性成分。

The medication label indicates 75 mcg of active ingredient.

目的：规范、统一药品标签与说明书的内容。

Objective: To standardize and unify the contents of drugs in labels and directions.

这份报告也指出，FDA准备下达强制的命令，即在药品标签中说明“不得给2岁以下的儿童使用”。

A. consider mandatory warning labels saying that they should not be used in children younger than 2.