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FDA published "Orange Book Questions and Answers".

This guidance is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book.

The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned abbreviated new drug applications (ANDAs), the movement of drug products between the Active and Discontinued sections in the Orange Book, and drug product and patent listings.

#fda #Learning #anda

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