Form Approved: OMB No. 0910-0001, Expiration Date: May 31, 2008, See OMB Statement on Page 3.

1. DATE SUBMITTED 3. NDA/ANDA/AADA OR BLA/PLA/PMA

Number:
TRANSMITTAL OF ADVERTISEMENTS
Single product Multiple products
AND PROMOTIONAL LABELING FOR
For multiple products, submit completed form and
DRUGS AND BIOLOGICS 2. LABEL REVIEW NO. (Biologics)
specimen of advertising/promotional materials to one
application of choice, and attach separate sheet address-
FOR HUMAN USE ing items 3-5 for remainder of products. Refer to No. 3 on
instruction sheet.

NOTE: Form 2253 is required by law. Reports are required for approved NDAs and ANDAs (21 CFR 314.81)
4. PROPRIETARY NAME 5. ESTABLISHED NAME

Prod. Code No.

6. PACKAGE INSERT DATE and ID NO. 7. MANUFACTURER NAME:
(Latest final printed labeling)
License No. (Biologics)

FDA/CBER USE ONLY

REVIEWED BY: DATE RETURNED BY: DATE

8. ADVERTISEMENT / PROMOTIONAL LABELING MATERIALS

Please check one or both: Professional Consumer
Material Type Dissemination/ Applicant's Material ID Code and/or description Previous review No. COMMENTS:
(use FDA codes) Publication Date if applicable / date
(PLA Submissions)
a. b. c. d.

9. TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT 10. SIGNATURE OF RESPONSIBLE OFFICIAL

11. APPLICANT'S RETURN ADDRESS 12. RESPONSIBLE OFFICIAL'S

a. PHONE NO.

b. FAX NO.

13. FOR CBER PRODUCTS ONLY: (Check one)

Part I/Draft Part II/Final

PREVIOUS EDITION IS OBSOLETE.

FORM FDA 2253 (9/06) PSC Graphic Arts (301) 443-1090 EF
 Instructions for Completing Form FDA 2253
1. Date Submitted - the date the 2253 Form and accompanying materials are sent to the FDA.

2. Original 2567 submission for biologics, leave blank. Resubmissions, include previously assigned "P" review number, if
known.
3. NDA/ANDA/AADA/PLA/BLA/PMA number. For CBER, include most recent reference number effecting a labeling change.
Single product - Each 2253 Form and accompanying submission should pertain to only one application number. The
completed Form and the attached submission materials should be prepared in duplicate, and should be separated for ease of
handling.
Multiple products. In cases where promotional materials mention multiple products such as price lists, formulary lists,
multiple product reminder ads, and corporate communications; three specimens of the promotional piece may be filed to a
single application with three 2253 Forms and labeling, and the other referenced products require only an attached sheet(s)
which identifies the other referenced products including: application No., trade name and established name, and labeling for
each referenced product.
4. Proprietary Name - enter the proprietary name of the drug or biological product. The dosage form should also be included if
it is part of the proprietary name or if it distinguishes the product from other dosage forms with the same trade name.
5. Established Name - the established (generic) name of the drug/biological product. For biological product submissions,
provide "Product Code No.", if known or used.
6. Package Insert Date & No. - the date and identification number of the most current approved product labeling (include two
copies).
7. Manufacturer name and license no. - provide this information for biological product submissions.

8. Advertising/Promotional Labeling Materials - A detailed listing of all promotional materials submitted on the
2253 Form. Each material should be individually listed per line.
8a. Material Type - List materials submitted using the FDA Codes listed below.
FDA CODE TRANSLATION FDA CODE TRANSLATION
CAD CONSUMER PRINT ADVERTISEMENTS PFK PROFESSIONAL PRINT FORMULARY KIT
CAT CONSUMER AUDIO (TAPE/SCRIPT) PGV PROFESSIONAL GIVEAWAYS
CCP CONSUMER COMPUTER DISCS/PROGRAMS/CD ROM PHO PROFESSIONAL HOUSE ORGAN
CDM CONSUMER DIRECT MAIL PLT PROFESSIONAL DIRECT MAIL
CED CONSUMER PROMOTIONAL LABELING (PRESCRIBER/PHARMACIST/WHOLESALER)
COT CONSUMER - OTHER PMN PRODUCT MONOGRAPHS
CRD CONSUMER RADIO (SCRIPT/TAPE) POT PROFESSIONAL - OTHER
CSK CONSUMER STARTER KITS PPO PROFESSIONAL PRINT -- OTHER
CTL CONSUMER TELEPHONE (SCRIPTS) PPR PRINT PRESS RELEASE
CTV CONSUMER TELEVISION (SCRIPT/STORYBOARD/VIDEO PRC PROFESSIONAL REPRINT CARRIERS
TAPE) PRD PROFESSIONAL RADIO (SCRIPT/TAPE)
CVT CONSUMER VIDEO (TAPE/STORYBOARD/SCRIPT) PRP PROFESSIONAL REPRINTS
PAD PROFESSIONAL PRINT AD PSA PROFESSIONAL SALES AID (DETAILER)
PAT PROFESSIONAL AUDIO TAPE/CD PSC PROFESSIONAL SAMPLE CARTON
PBK PROFESSIONAL BOOK PSL PROFESSIONAL SLIDES
PCP PROFESSIONAL COMPUTER DISCS/PROGRAMS/CD ROMS PTL PROFESSIONAL TELEPHONE (SCRIPT)
PCT PROFESSIONAL PRICE CATALOGS PTV PROFESSIONAL TELEVISION(SCRIPT/STORYBOARD/VIDEO TAPE)
PDS PROFESSIONAL DRUG SAMPLE PVT PROFESSIONAL VIDEO TAPE
PEP PROFESSIONAL EXHIBIT PANEL VNR VIDEO NEWS RELEASES
PFC PROFESSIONAL FILE CARD WWW INTERNET PROMOTION
PFE PROFESSIONAL FORMULARY ECONOMIC OM OTHER MISCELLANEOUS (EXPLAIN)

8b. Dissemination/Publication Date - the date of the initial dissemination of the promotional labeling or the date of initial
publication for a journal advertisement.
8c. Applicant’s Material ID Code - the applicant’s identification code or other designation of the specific promotional material.

8d. Previous review No. and date if biological product submission, if applicable.

9. Typed Name and Title of Responsible Official - the individual responsible for responding to any inquires regarding the 2253
submission.
10. Signature of Responsible Official
11. Applicant’s Return Address

12a & b. Telephone and FAX Numbers - the telephone and facsimile numbers of the responsible official.

Biological products: check #1 if submitting draft; check #2 for final copy.

NOTE: Forward Form and attachments for drugs to: Food and Drug Administration, Center for Drug Evaluation and
Research, Division of Drug Marketing, Advertising, and Communication, 5901-B Ammendale Road, Beltsville,
MD 20705
Forward Form and attachments for biologics to: Department of Health and Human Services,
Food and Drug Administration, CBER (HFM-202), 1401 Rockville Pike, Rockville, MD 20852-1448.

FORM FDA 2253 (9/06)

 Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing
this burden to:

Food and Drug Administration An agency may not conduct or sponsor, and a person is not required to respond to, a
Center for Drug Evaluation and Research collection of information unless it displays a currently valid OMB control number.
Division of Drug Marketing, Advertising, and Communications
5901-B Ammendale Road
Beltsville, MD 20705
Please DO NOT RETURN this form to this address.

FORM FDA 2253 (9/06)