FORM FDA 356h

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Form Approved: OMB No. 0910-0001
Expiration Date: 07/31/2027
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)
APPLICANT INFORMATION
2. Name of Applicant
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
Address 1 (Street address, P.O. box, company name c/o)

Email Address

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

Applicant DUNS

City

State/Province/Region

Country

ZIP or Postal Code

U.S. License Number if
previously issued

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

First Name

Middle Last Name

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

Title
Telephone Number (Include area code)

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

U.S. Agent DUNS FAX Number (Include area code)

City

State

ZIP Code

Email Address

PRODUCT DESCRIPTION
7. NDA, ANDA, or BLA Application Number

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
15A. Proposed Indication for Use

13. Strengths

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

15B. Primary SNOMED CT Indication Term

Yes

No

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

15C. Secondary SNOMED CT Indication Term(s)
Continuation
Page for #15

Form FDA 356h (05/26) (PREVIOUS EDITION OBSOLETE)

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APPLICATION INFORMATION
16. Application Type (Select one)
New Drug Application (NDA)

Biologics License Application (BLA)

Abbreviated New Drug Application (ANDA)
17. If an NDA, identify the type
505(b)(1)
505(b)(2)

18. If a BLA, identify the type
351(a)
351(k)

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

Reference Product BLA Number:

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

Continuation
Page for #20

Name of Drug:
Relied Upon Product Application Type: Select One
Indicate Patent Certification:

P1

P2

Application Number:
P3

P4

Section viii – MOU

For an ANDA, has a Suitability Petition been submitted for this product?
21. Submission (See instructions)
Original

Yes

No

Statement of no relevant patents
If yes, was it approved?

Yes

No

Labeling Supplement

CMC Supplement

Efficacy Supplement

Annual Report

Product Correspondence

Postmarketing Requirements or Commitments

Request for Proprietary Name Review

Periodic Safety Report

REMS Supplement

REMS Assessment Report

REMS Assessment Methods and Study Protocols
Human Factors (Specify Type):
Other (Specify):
22. Submission Sub-Type
Presubmission
Initial Submission

23. If a supplement, identify the appropriate category.
Prior Approval (PA)
CBE

Amendment
Resubmission

CBE-30

24. For Originals and all Supplements,
Combination Product Type Request for Designation 25. Proposed Marketing Status (Select one)
is the product a combination product (See instructions)
(RFD) Number
Prescription Product (Rx)
(21 CFR 3.2(e))?
Over-The-Counter Product (OTC)
Yes
No
26. Does the submission contain:
New Pediatric Labeling? Digital Health Technologies (DHT) data?” Real-world evidence (RWE) or a proposal to use RWE?
Yes

No

Yes

No

Yes

No

27. Reasons for Submission

28. Establishment Information (Full establishment information should be provided in the body of the application.)
Establishment Name

Registration (FEI) Number

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

MF Number

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

Establishment DUNS Number

City
Is the establishment new
to the application?
Yes
No

State/Province/Region

ZIP or Postal Code Country

Is this establishment involved in the
change described in this supplement?
Yes
No

Form FDA 356h (05/26) (PREVIOUS EDITION OBSOLETE)

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What is the status of the establishment?
Pending
Active
Inactive
Withdrawn

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Establishment Contact Information at the site/facility
First Name

Middle Last Name

Title

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

Telephone Number (Include area code)

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

FAX Number (Include area code)

City

State/Province/Region

Country

Email Address
ZIP or Postal Code

Manufacturing Steps and/or Type of Testing

Is the site ready for inspection?
Yes
No
N/A
If No, when will site be ready?
(mm/dd/yyyy)
Continuation Page for #28

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

Continuation
Page for #29

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

Index

2.

Labeling (Select one):
Draft Labeling
Final Printed Labeling

3.

Summary (21 CFR 314.50 (c))

4.

Chemistry Section
A.

B.

C.

5.

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

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.

14.

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

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.

8.

Clinical data section (e.g., 21 CFR
314.50(d)(5); 21 CFR 601.2)

Establishment description (21 CFR
Part 600, if applicable)

16.

9.

Safety update report (e.g., 21 CFR
314.50(d)(5)(vi)(b); 21 CFR 601.2)

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

17.

10.

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

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

18.

11.

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

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

12.

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

19.

Financial Disclosure Information (21
CFR Part 54)

13.

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

20.

Other (Specify):

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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.
31. Applicant’s Responsible Official
First Name
32. Date (mm/dd/yyyy)

Middle

Last Name

Title

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

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

35. Email Address
36. 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
37. Signature of Applicant’s Responsible Official or
Other Authorized Official

ZIP or Postal Code

Sign

38. Countersignature of Authorized U.S. Agent

Sign

THE INFORMATION BELOW APPLIES ONLY TO REQUIREMENTS OF THE PAPERWORK REDUCTION ACT OF 1995.
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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 the
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Form FDA 356h (05/26) (PREVIOUS EDITION OBSOLETE)

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