FDA Form 356h PROPOSED

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Form Approved: OMB No. 0910-0338
Expiration Date: Xxxxxx xx, 20xx
See PRA Statement on page 3.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

APPLICATION TO MARKET A NEW OR ABBREVIATED NEW
DRUG OR BIOLOGIC FOR HUMAN USE

1. Date of Submission (mm/dd/yyyy)

(Title 21, Code of Federal Regulations, Parts 314 & 601)
2. Name of Applicant

APPLICANT INFORMATION

3. Telephone Number (Include country code if applicable and area code) 4. Facsimile (FAX) Number (Include country
code if applicable and area code)
5. Applicant Address
Email Address

Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)

Applicant DUNS

State/Province/Region

City

U.S. License Number if previously issued

ZIP or Postal Code

Country

6. Authorized U.S. Agent (Required for non-U.S. applicants)
Authorized U.S. Agent Name

Telephone Number (Include area code)

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

FAX Number (Include area code)

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

City

U.S. Agent DUNS

ZIP Code

7. NDA, ANDA, or BLA Application Number

PRODUCT DESCRIPTION

8. Supplement Number (If applicable)

9. Established Name (e.g., proper name, USP/USAN name)
10. Proprietary Name (Trade Name) (If any)
11. Chemical/Biochemical/Blood Product Name (If any)
12. Dosage Form

13. Strengths

15. Proposed Indication for Use

14. Route of Administration

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

16. Application Type
(Select one)

APPLICATION INFORMATION
17. If an NDA, identify the type

New Drug Application (NDA)

No

Contin.
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#15

Biologics License Application (BLA)

Abbreviated New Drug Application (ANDA)

18. If a BLA, identify the type

505(b)(2)

505(b)(1)

If yes, provide the Orphan
Designation number for this
indication:

Yes

351(a)

351(k)

19. If a 351(k), identify the biological reference product that is the basis for the submission.
Name of Biologic:

Holder of Licensed Application:

20. If an ANDA, or 505(b)(2), identify the listed drug product(s) that is/are the basis for the submission.
Name of Drug(s):

Application Number(s) of Relied Upon Product(s):

Indicate Patent Certification(s):

P1

P2

21. Submission (See
instructions)
Product Correspondence

Original

P4

Labeling Supplement

REMS Supplement

Request for Proprietary Name Review

FORM FDA 356h (8/17)

P3

Section viii - MOU
CMC Supplement

Statement of no relevant patents
Efficacy Supplement

Postmarketing Requirements or Commitments

Annual Report

Periodic Safety Report

Other (Specify):

Page 1 of 3

PSC Publishing Services (301) 443-6740

EF

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22. Submission
Sub-Type

Next Page

Presubmission

Amendment

Initial Submission

Resubmission

23. If a supplement, identify
the appropriate category.

CBE

Prior Approval (PA)

CBE-30

24. Does this submission contain:
Only Pediatric data?

Yes

Human Factors information?

No

Yes

No

25. Reasons for Submission

26. Proposed Marketing Status (Select one)
Prescription Product (Rx)

Over-The-Counter Product (OTC)

27. Establishment Information (Full establishment information should be provided in the body of the application.)
Refer to the instruction sheet (Form FDA 356h Supplement) for more information.
Establishment Name
Address 1 (Street address, P.O. box, company name c/o)

Registration (FEI) Number

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

MF Number

State/Province/Region

Country

ZIP or Postal Code

Is the establishment new to the application?
Yes

Establishment DUNS Number

What is the status of the establishment?
Pending
Active

No

Inactive

Withdrawn

Establishment Contact Information at the site/facility
Name of Contact for the Establishment

Telephone Number (Include area code)

Address 1 (Street address, P.O. box, company name c/o)
FAX Number (Include area code)

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

State/Province/Region

Country

Email Address

ZIP or Postal Code
Is the site ready
Yes
for inspection?
If No, when will site be
ready? (mm/dd/yyyy)

Manufacturing Steps and/or Type of Testing

No

N/A

Continuation Page for #27

28. Cross References (List related BLAs, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, MAFs, and DMFs referenced in the current application.)

Contin.
Page for
#28

29. This application contains the following items (Select all that apply)
1. Index

2. Labeling (Select one):

4. Chemistry Section

Draft Labeling

Final Printed Labeling

3. Summary (21 CFR 314.50 (c))

A. Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
B. Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA’s request)
C. Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)

5. Nonclinical pharmacology and toxicology section
(e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)

6. Human pharmacokinetics and bioavailability section
(e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)

7. Clinical microbiology section (e.g., 21 CFR 314.50(d)(4))

8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)
Item 29 continued on page 3

FORM FDA 356h (8/17)

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29. This application contains the following items (Continued; select all that apply)
9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b);
21 CFR 601.2)

10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)

11. Case report tabulations (e.g., 21 CFR 314.50(f)(1);
21 CFR 601.2)

12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)

13. Patent information on any patent that claims the drug/
biologic (21 U.S.C. 355(b) or (c))

14. A patent certification with respect to any patent that claims the
drug/biologic (21 U.S.C. 355 (b)(2) or (j)(2)(A))

15. Establishment description (21 CFR Part 600, if applicable)

16. Debarment certification (FD&C Act 306 (k)(1))

17. Field copy certification (21 CFR 314.50 (l)(3))

18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA Form
FDA 3794, BsUFA Form FDA 3792, or MDUFA Form FDA 3601)

19. Financial Disclosure Information (21 CFR Part 54)
20. Other (Specify):

CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, I agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to, the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202.
5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71, 314.72, 314.97, 314.99, and 601.12.
6. Regulations on Reports in 21 CFR 314.80, 314.81, 600.80, and 600.81.
7. Local, state, and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market
the product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and accurate.
Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
30. Typed Name and Title of Applicant’s Responsible Official
32. Telephone Number (Include country
code if applicable and area code)

31. Date (mm/dd/yyyy)

33. FAX Number (Include country code if
applicable and area code)

34. Email Address

35. Address of Applicant’s Responsible Official
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City

State/Province/Region

Country

ZIP or Postal Code

36. Signature of Applicant’s Responsible Official or
Other Authorized Official

Sign

37. Countersignature of Authorized U.S. Agent

Sign

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FORM FDA 356h (8/17)

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