f. Comments
This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit. This can be a very-ver long test. Just fill it with some random words, repeat and profit.
Number: XYZ1231
Type: Some type
Multiple products
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.
3. NDA/ANDA/AADA or BLA/PMA
Single product
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
TRANSMITTAL OF ADVERTISEMENTS
AND PROMOTIONAL LABELING FOR
DRUGS AND BIOLOGICS
FOR HUMAN USE
2. Label Review Number (Biologics)
12312A1BCD
1. Date Submitted
22.04.2019
Professional
Consumer
Product Code No.:
A13123919231
5. Established Name
The name of the product.
4. Proprietary Name
The name of the product. Can be very-very long.
Some Company Name Inc
7. Manufacturer Name
NOTE: Form FDA 2253 is required by law. Reports are required for approved NDAs and ANDAs (21 CFR 314.81).
GB21231
License No. (Biologics):
2019-04-01 12312
6. Package Insert Date and ID Number
(Latest final printed labeling)
Form Approved: OMB No. 0910-0001, Expiration Date: March 31, 2021; see PRA Statement on last page.
Material Type
(use FDA codes)
b.
Dissemination/
Publication
Date
c.
Material ID Code
d.
Material Description
e.
Audio
21.04.2001
F1231
Some long text here. Some long text here. Some long text here. Some long text here. Some long text here. Some long text here.
Book
21.04.2001
F1231
Some long text here. Some long text here. Some long text here. Some long text here. Some long text here. Some long text here.
CD-ROM
21.04.2001
F1231
Some long text here. Some long text here. Some long text here. Some long text here. Some long text here. Some long text here.
File Card
21.04.2001
F1231
Some long text here. Some long text here. Some long text here. Some long text here. Some long text here. Some long text here.
8.
Advertisement / Promotional Labeling Materials
a. Please check only one:
Page 1 of 2
FORM FDA 2253 (03/18)
PREVIOUS EDITION IS OBSOLETE
Missouri
State/Province/Region
Kansas City
b. FAX Number (Include area code)
a. Telephone Number (Include area code)
c. Email Address
Address 2 (Apartment, suite, unit, building, floor, etc.)
john.smith@companyname.com
Address 1 (Street address, P.O. box, company name c/o)
9. Applicant’s (or Agent’s) Return Address
64030
ZIP or Postal Code
Suite 312/F
Country
61 North Summit Street
United States
+37291923121
City
+37213123191923
10. Responsible Official’s (or Agent’s)
Final
Draft
14. For CBER Products Only (Check one)
image
John von Longname Smith
23.04.2019
12. Signature of Responsible Official or Agent
13. Date
11. Typed Name and Title of Responsible Official or Agent
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
PRAStaff@fda.hhs.gov

“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.”
Page 2 of 2
FORM FDA 2253 (03/18)
PREVIOUS EDITION IS OBSOLETE