If a sample is selected from a batch not described in the application, an amendment containing a copy of the batch record and certificate of analysis should be provided to the ANDA.

  • 如果样品是来自于一申请中未提及的批次的话,则在ANDA中还应当要补充一份批记录和分析报告单的复印件。

  • 互联网摘选 2025-01-20 18:19:04

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