Abbreviated New Animal Drug Applications

OMB 0910-0669

OMB 0910-0669

This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application.

The latest form for Abbreviated New Animal Drug Applications expires 2022-10-31 and can be found here.

OMB Details

Abbreviated New Animal Drug Applications

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 356vApplication for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)Fillable Fileable SignableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.


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