Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

OMB 0910-0513

OMB 0910-0513

The information collection supports Form FDA 3542 and 3542a as used by new drug application (NDA) holders to submit patent declarations as prescribed by agency regulations. The information collected is required by statue and used by the agency for listing such information in the "Orange Book."

The latest form for Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That... expires 2022-10-31 and can be found here.

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Form FDA 3542

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3542Patent Declaration After Filing NDA or SupplementFillable FileableForm and instruction

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