Fda 2253 Transmittal Of Advertisements And Promotional Labeling F

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0001
Expiration Date: March 31, 2024
See PRA Statement on last page.

TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL
LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Single product

2. Application Information

Multiple products

Application Type:

1. Date Submitted

For multiple products, submit completed form and
specimen of advertising/promotional materials to one
application of choice, and attach separate sheet
addressing items 3-5 for remainder of products. Refer
to No. 3 on instruction sheet.

NDA
/
ANDA
BLA
NOTE: Form FDA 2253
is required by law. Reports are required for approved NDAs, ANDAs (21 CFR 314.81), and BLAs (601.12(f)(4))
3. Proprietary Name PMA
4. Established Name
CDER IND
Application Number:

Product Code No.:

6. Manufacturer Name

5. Package Insert Date and ID Number
(Latest final printed labeling)

License No. (Biologics):

7.

Advertisement / Promotional Labeling Materials

a. Please check only one:
Material Type
(use FDA codes)
b.

Professional
Dissemination/
Publication
Date
c.

Consumer
Material ID Code

Material Description

d.

e.

Delete
Row
To delete a row, click the “Delete Row” button for that row (or press the enter key
if you’ve tabbed into the button). You cannot delete the last remaining row.

Add New Row

f. Comments

8. Applicant’s (or Agent’s) Return Address

9. Responsible Official’s (or Agent’s)
a. Telephone Number (Include area code)

Address 1 (Street address, P.O. box, company name c/o)

Address 2 (Apartment, suite, unit, building, floor, etc.)

City

b. FAX Number (Include area code)

State/Province/Region
c. Email Address

Country

ZIP or Postal Code

FORM FDA 2253 (04/21) PREVIOUS EDITION IS OBSOLETE

Page 1 of 2

PSC Publishing Services (301) 443-6740

EF

10. Typed Name and Title of Responsible Official or Agent 11. Signature of Responsible Official or Agent

12. Date

Sign
13. For CBER Products Only (Check one)
Draft

Final

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 2 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any
other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 2253 (04/21) PREVIOUS EDITION IS OBSOLETE

Page 2 of 2