Applications for FDA Approval to Market a New Drug

ICR 202402-0910-003

OMB: 0910-0001

Federal Form Document

Forms and Documents

Document Name	Status
Form FDA 3331a Subpart B - Applications Form and Instruction	Modified
Form FDA 3938 PART 314: Subparts E through I Form	Modified
0001 NDAs SSA 2024 REV.docx Supporting Statement A	2024-03-06
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01

IC Document Collections

IC ID	Document Title	Status
5662	Subpart B - Applications Form and Instruction	Modified
184605	PART 314: Subparts E through I Form	Modified
184601	Subpart D - FDA Action on Applications Other-Agency Guidance	Modified
184600	Subpart C - Abbreviated Applications Other-Agency Guidance	Modified