Form FDA 356h: Application to Market a New or Abbreviated New Drug or Biologic

Enter the Date of Submission (mm/dd/yyyy) in Box 1 and the Name of Applicant in Box 2.

Enter the Telephone Number in Box 3 and the Facsimile (FAX) Number in Box 4, including country code if applicable and area code.

In Box 5, Applicant Address, enter Address 1 (Street address, P.O. box, company name c/o), Address 2 (Apartment, suite, unit, building, floor, etc.), City, State/Province/Region, Country and ZIP or Postal Code.

Enter the Email Address, the Applicant DUNS and the U.S. License Number if previously issued.

Box 6, Authorized U.S. Agent, is Required for non-U.S. applicants.

In Box 6, enter the U.S. Agent Company, First Name, Middle, Last Name, Title, Address 1, Address 2, City, State and ZIP Code.

In Box 6, enter the Telephone Number (Include area code), FAX Number (Include area code), Email Address and U.S. Agent DUNS.

Enter the NDA, ANDA, or BLA Application Number in Box 7 and the Supplement Number (If applicable) in Box 8.

Enter the Established Name (e.g., proper name, USP/USAN name) in Box 9, the Proprietary Name (Trade Name) (If any) in Box 10 and the Chemical/Biochemical/Blood Product Name (If any) in Box 11.

Enter the Dosage Form in Box 12, the Strengths in Box 13 and the Route of Administration in Box 14.

Enter the Proposed Indication for Use in Box 15A and mark Yes or No: Is this indication for a rare disease (prevalence <200,000 in U.S.)?

Does this product have an FDA Orphan Designation for this indication? If yes, provide the Orphan Designation number for this indication: DRU-YYYY-.

Enter the Primary SNOMED CT Indication Term in Box 15B and the Secondary SNOMED CT Indication Term(s) in Box 15C.

In Box 16, Application Type (Select one), mark New Drug Application (NDA), Biologics License Application (BLA) or Abbreviated New Drug Application (ANDA).

In Box 17, if an NDA, identify the type: 505(b)(1) or 505(b)(2).

In Box 18, if a BLA, identify the type: 351(a) or 351(k).

In Box 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 and Reference Product BLA Number.

In Box 20, if an ANDA, or 505(b)(2), identify the listed drug product that is/are the basis for the submission: Name of Drug, Relied Upon Product Application Type and Application Number.

In Box 20, Indicate Patent Certification: P1, P2, P3, P4, Section viii - MOU or Statement of no relevant patents.

In Box 20, for an ANDA, has a Suitability Petition been submitted for this product? Yes No. If yes, was it approved? Yes No.

In Box 21, Submission (See instructions), mark Original, 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) or Other (Specify).

In Box 22, Submission Sub-Type, mark Presubmission, Amendment, Initial Submission or Resubmission.

In Box 23, if a supplement, identify the appropriate category: CBE, CBE-30 or Prior Approval (PA).

In Box 24, for Originals and all Supplements, mark Yes or No: is the product a combination product (21 CFR 3.2(e))? Enter the Combination Product Type (See instructions) and the Request for Designation (RFD) Number.

In Box 25, Proposed Marketing Status (Select one), mark Prescription Product (Rx) or Over-The-Counter Product (OTC).

In Box 26, mark Yes or No: does the submission contain New Pediatric Labeling, Digital Health Technologies (DHT) data or Real-world evidence (RWE) or a proposal to use RWE?

Enter the Reasons for Submission in Box 27.

In Box 28, Establishment Information (Full establishment information should be provided in the body of the application.), enter the Establishment Name, Registration (FEI) Number, Address 1, MF Number, Address 2, Establishment DUNS Number, City, State/Province/Region, ZIP or Postal Code and Country.

Is the establishment new to the application? Yes No. Is this establishment involved in the change described in this supplement? Yes No. What is the status of the establishment? Pending, Active, Inactive or Withdrawn.

Under Establishment Contact Information at the site/facility, enter First Name, Middle, Last Name, Title, Address 1, Telephone Number (Include area code), Address 2, FAX Number (Include area code), City, State/Province/Region, Email Address, Country and ZIP or Postal Code.

Enter the Manufacturing Steps and/or Type of Testing, and mark Yes, No or N/A: Is the site ready for inspection? If No, enter when the site will be ready (mm/dd/yyyy).

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

In Box 30, select all that apply of the items this application contains. For Labeling (Select one), mark Draft Labeling or Final Printed Labeling.

Samples: Submit only upon FDA's request.

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.

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.

In Box 31, Applicant's Responsible Official, enter First Name, Middle, Last Name and Title.

Enter the Date (mm/dd/yyyy) in Box 32, the Telephone Number in Box 33 and the FAX Number in Box 34, including country code if applicable and area code, and the Email Address in Box 35.

In Box 36, Address of Applicant's Responsible Official, enter Address 1, Address 2, City, State/Province/Region, Country and ZIP or Postal Code.

Box 37 is the Signature of Applicant's Responsible Official or Other Authorized Official.

Box 38 is the Countersignature of Authorized U.S. Agent.

Form FDA 356h is the application to market a new or abbreviated new drug or biologic for human use (Title 21, Code of Federal Regulations, Parts 314 & 601). The form prints Form Approved: OMB No. 0910-0001 and Expiration Date: 07/31/2027.

In Box 30, select all that apply: 18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA Form FDA 3794, BsUFA Form FDA 3792, or MDUFA Form FDA 3601).