Abbreviated New Animal Drug Applications

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.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 356v Phased Review with Administrative ANADA Form and Instruction
Form FDA 356v Abbreviated New Animal Drug Applications Form and Instruction
0910-0669SupportingStatement2022 Final 9-23-22.docx Supporting Statement A
Biowaiver request: Type A medicated article, using same API/solubility approach Other-Guidance
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach Other-Guidance
Biowaiver request: powder oral dosage form, using same API/solubility approach Other-Guidance
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach Other-Guidance
Phased Review with Administrative ANADA Form and Instruction
Abbreviated New Animal Drug Applications Form and Instruction

All Historical Document Collections

202202-0910-008 Approved without change	Extension without change of a currently approved collection	2022-09-27
201908-0910-009 Approved without change	Revision of a currently approved collection	2019-09-09
201608-0910-009 Approved without change	Extension without change of a currently approved collection	2016-09-07
201309-0910-007 Approved without change	Extension without change of a currently approved collection	2013-09-17
201004-0910-009 Approved without change	Existing collection in use without an OMB Control Number	2010-04-30

OMB Details

Abbreviated New Animal Drug Applications

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 356v

Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)

Fillable Fileable Signable

Form and instruction

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