Prescription Drug Product Labeling; Medication Guide Requirements

ICR 202210-0910-010

OMB: 0910-0393

Federal Form Document

Forms and Documents

Document Name	Status
0393 Patient Medication Guides SSA 2022 EXT.docx Supporting Statement A	2022-10-31
PDUFA User Fee Schedule 87 FR 61063 Oct 7 2022.pdf Supplementary Document	2022-10-24

IC Document Collections

IC ID	Document Title	Status
6050	Content and Format of a Medication Guide	Modified
205325	Distributing and Dispensing a Medication Guide to Patients	Modified
188594	Distributor Provides Medication Guide to Dispenser	Unchanged
187331	Exemptions and Deferrals	Unchanged
187330	Supplements and Other Changes to an Approved Application	Removed