How to Fill Out FDA Form 0356H (w/Examples) + FAQs

FDA Form 0356H is the required cover sheet for all applications seeking FDA approval to market new drugs, generic drugs, and biological products in the United States. Under 21 CFR 314.50 and 21 CFR 601.2, you cannot submit a New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or Biologics License Application (BLA) without this form.

An error on Form 0356H is one of the top reasons the FDA rejects eCTD submissions outright. The consequences are serious: a Refuse-to-Receive (RTR) designation, extended review timelines, or additional FDA queries that delay your product’s path to market by months or even years.

According to FDA data from 2024-2025, the most common Form 0356H discrepancies account for approximately 40% of information requests sent to ANDA applicants—problems that are entirely preventable with proper preparation.​​

In this article, you will learn:

📋 How to complete every field of Form 0356H with step-by-step guidance for NDAs, ANDAs, and BLAs

⚠️ The 10 most common mistakes that trigger Refuse-to-Receive letters and how to avoid them

💰 User fee requirements including PDUFA ($4.68 million for FY 2026) and GDUFA ($358,247) fees and which forms accompany your application

🏭 Facility listing requirements including FEI numbers, DUNS numbers, and inspection-readiness certifications

📝 Patent certification strategies (Paragraphs I-IV) and their downstream legal implications for generic applicants

What Is FDA Form 0356H?

FDA Form 0356H serves two primary functions. First, it acts as an administrative summary that allows FDA staff to properly route and file your submission. Second, it provides a complete record of all manufacturing facilities involved in producing your drug substance and drug product.

The form collects information in four main categories: applicant identification, product description, application type, and manufacturing establishment details. Every submission—whether an original application, supplement, amendment, or resubmission—requires this form.

Who Must Submit Form 0356H?

The FDA revised Form 0356H in July 2023, adding enhanced usability features. The current version has an expiration date of March 31, 2026. Using an outdated version may result in your submission being rejected.

Application Types: Understanding Your Pathway

Before completing Form 0356H, you must determine which regulatory pathway applies to your product. The form requires you to select one application type in Field 16.​

New Drug Applications (NDAs)

NDAs are governed by Section 505 of the Federal Food, Drug, and Cosmetic Act. There are two NDA types to select in Field 17:

505(b)(1) NDA: A “stand-alone” application containing full reports of safety and effectiveness investigations conducted by or for the applicant. This pathway requires complete clinical data packages demonstrating the drug is safe and effective for its intended use.

505(b)(2) NDA: An application that relies, at least in part, on data from studies not conducted by or for the applicant. This pathway allows applicants to reference published literature or the FDA’s previous approval of a related drug. Common uses include:

Abbreviated New Drug Applications (ANDAs)

ANDAs provide an abbreviated approval pathway for generic drugs under Section 505(j). Generic applicants do not need to repeat clinical trials. Instead, they demonstrate their product is bioequivalent to a Reference Listed Drug (RLD) identified in the FDA’s Orange Book.

In Field 20, ANDA applicants must identify the RLD and provide patent certifications.

Biologics License Applications (BLAs)

BLAs are submitted under Section 351 of the Public Health Service Act. Select the appropriate type in Field 18:

351(a) BLA: The “full” pathway requiring complete data demonstrating the biological product is safe, pure, and potent. This includes clinical trial data for each sought indication.

351(k) BLA: The biosimilar pathway for products demonstrated to be “highly similar” to an FDA-licensed reference product. Applicants must provide analytical, animal, and clinical data showing biosimilarity.

Completing Form 0356H: Field-by-Field Instructions

The FDA’s official instructions supplement provides guidance for each field. Below is a detailed walkthrough covering nuances and common pitfalls.​

Section 1: Date of Submission (Field 1)

Enter the date you are submitting the application to the FDA. This date should match your cover letter date. For electronic submissions via the FDA Electronic Submissions Gateway (ESG), ensure this date reflects when you transmit the submission, not when you prepared it.

Section 2: Applicant Information (Fields 2-6)

This section captures the legal identity of the applicant—the company or individual responsible for the application.

Critical: The applicant DUNS number in Field 5 is essential. The Data Universal Numbering System (DUNS) is a unique nine-digit identifier issued by Dun & Bradstreet that the FDA uses to verify your business identity. A mismatch between your DUNS number and your actual business registration will trigger an information request.​

For foreign applicants, you must designate a U.S. Agent in Field 6. The U.S. Agent can sign the application and serve as the FDA’s primary contact.​

Section 3: Product Description (Fields 7-15)

This section identifies the specific drug product covered by your application.

Field 7 – Application Number: For original applications, leave this blank (the FDA will assign a number). For supplements, amendments, and resubmissions, enter your existing six-digit application number. Pad shorter numbers with leading zeros (e.g., NDA 12345 becomes 012345).​

Field 8 – Supplement Number: Only complete this for supplemental applications.​

Fields 9-14 – Product Identification:

Field 15 – Proposed Indication for Use: For original applications and efficacy supplements only. Include:​

• The proposed therapeutic indication(s)​
• Whether the indication is for a rare disease (prevalence <200,000 U.S. patients)​
• Whether the product has FDA Orphan Drug Designation​
• The six-digit Orphan Designation number, if applicable​

Real-World Scenario: Sarah at BioGen Pharmaceuticals is submitting an NDA for a new oncology drug targeting a rare form of leukemia affecting approximately 8,000 Americans annually. In Field 15, she indicates “Yes” for rare disease and enters her Orphan Designation number (OD-2024-00234). This designation exempts BioGen from the $4.68 million PDUFA application fee under Section 736(a)(1)(F).

Section 4: Application Information (Fields 16-30)

Fields 16-18 – Application Type Selection:

Field 19 – Biosimilar Reference Product: For 351(k) BLAs only. Identify the licensed reference product name and application holder.

Field 20 – ANDA or 505(b)(2) Basis for Submission: This field is critical for generic and hybrid applications.

For ANDAs, you must:

1. Identify the Reference Listed Drug (RLD) by name and NDA number​
2. Provide patent certifications (Paragraphs I, II, III, or IV)

Patent Certifications Explained

Patent certifications are legally consequential statements affecting when the FDA can approve your generic drug.

Paragraph IV certifications trigger a patent challenge process. After the FDA determines your ANDA is “substantially complete,” you must notify the brand-name manufacturer and patent holders within 20 days. If the patent holder sues within 45 days, FDA approval is typically stayed for 30 months unless the patent is invalidated or found not infringed sooner.

Real-World Scenario: Marcus at GenericRx files an ANDA for a generic version of a cardiovascular drug with three Orange Book-listed patents. Two patents have expired (Paragraph II), but one remains active until 2028. Marcus believes his formulation does not infringe the active patent. He submits a Paragraph IV certification, prepares for patent litigation, and budgets for 30 months of potential delay before approval.​

Field 21 – Submission Type: Select all applicable options:

Fields 22-27 – Supplement and Submission Details: These fields capture supplement classification (Prior Approval, CBE-30, CBE-0) and additional submission characteristics.

Field 28 – Establishment Information: This is often the most error-prone section of Form 0356H.​​

For each manufacturing, packaging, and testing site, provide:

• Facility name and complete address​
• FEI (FDA Establishment Identifier) number
• DUNS number​
• Whether the facility is new to the application​
• Facility status (Active, Pending, or Withdrawn)​
• Manufacturing steps performed at the site​
• Whether the site is ready for FDA inspection

Field 30 – Submission Checklist: Check all items included in your submission:

Section 5: Certification (Fields 31-38)

The responsible official must sign Field 37, certifying that all information is accurate and complete. For foreign applicants, the U.S. Agent may countersign in Field 38.​

Signature Requirements: The FDA accepts scanned signatures, digital signatures, and flattened digital signatures. If using digital signatures, include the signer’s name, date, reason for signing, and visual representation.​

Related Forms That Accompany Form 0356H

Form 0356H does not stand alone. Several other forms must accompany your submission.

Form FDA 3397 – PDUFA User Fee Cover Sheet

Required for NDAs and BLAs subject to Prescription Drug User Fee Act (PDUFA) fees.

FY 2026 PDUFA Fees:​

Complete Form FDA 3397 online at the FDA User Fee System. Your NDA/BLA is considered incomplete without payment.

Orphan Drug Exemption: Products with FDA Orphan Designation are exempt from PDUFA application fees unless seeking approval for a non-rare disease indication.

Form FDA 3794 – GDUFA User Fee Cover Sheet

Required for ANDAs subject to Generic Drug User Fee Amendments (GDUFA) fees.

FY 2026 GDUFA Fees:

Place the signed GDUFA cover sheet in the first volume with Form 0356H.​

Form FDA 3674 – ClinicalTrials.gov Certification

Required for applications containing clinical trial data under 42 U.S.C. § 282(j).

Select one certification option:​

If selecting Box C, list all NCT (National Clinical Trial) numbers for applicable clinical trials.​

Forms FDA 3454/3455 – Financial Disclosure

Required for applications containing clinical data. These forms address potential conflicts of interest among clinical investigators.

Form FDA 3454 (Certification): Used when clinical investigators have no disclosable financial interests.​

Form FDA 3455 (Disclosure): Used when investigators have disclosable financial interests exceeding $25,000, including:

• Compensation tied to study outcome
• Equity interests in sponsor
• Proprietary interests (patents, royalties)

Electronic Submission via FDA ESG

Since May 2017, all commercial INDs, NDAs, BLAs, and ANDAs must be submitted electronically through the FDA Electronic Submissions Gateway (ESG) in eCTD format.

ESG NextGen Options:​

Form 0356H Placement in eCTD: Place the fillable PDF in Module 1, Section 1.2 of the eCTD structure.

Pre-Submission Validation

Before transmitting, validate your submission locally:​

• Run eCTD validation against current FDA DTD
• Verify all checksums
• Check PDF compliance
• Validate hyperlinks
• Confirm file naming conventions

A missing or incomplete Form 0356H is among the top reasons for eCTD rejection.​

Mistakes to Avoid: Top 10 Form 0356H Errors

Based on FDA presentations and guidance, these are the most common Form 0356H discrepancies:​​

Real-World Scenarios

Scenario 1: First-Time NDA Applicant

Situation: Rachel at NovaPharma is submitting her company’s first NDA for a new diabetes medication. NovaPharma is a small business with fewer than 500 employees.

Form 0356H Considerations:

• Field 16: Select “New Drug Application (NDA)”
• Field 17: Select “505(b)(1)” (full clinical data package)
• Field 15: Indicate proposed indication (Type 2 diabetes); not a rare disease
• Field 28: List all manufacturing facilities (2 API sites, 1 FDF site, 1 testing laboratory)
• Field 30: Check all applicable items including User Fee Cover Sheet (Item 18)

User Fee: Rachel completes Form FDA 3397. Because NovaPharma qualifies as a small business submitting its first NDA, she requests a fee waiver under PDUFA waiver provisions. If approved, the waiver saves NovaPharma $4.68 million.

Scenario 2: Generic Drug (ANDA) with Paragraph IV Certification

Situation: David at GenPharm is filing an ANDA for a generic version of a blockbuster cholesterol medication.

What Happens Next:

1. FDA reviews ANDA for substantial completeness​
2. If substantially complete, FDA notifies David​
3. David has 20 days to notify the NDA holder and patent owner​
4. If patent holder sues within 45 days, a 30-month stay begins​
5. If no lawsuit, FDA can approve when ANDA is ready​

Scenario 3: Biosimilar BLA (351(k))

Situation: Lisa at BioSim Inc. is submitting a 351(k) BLA for a biosimilar to an FDA-licensed monoclonal antibody.

Key Consideration: For BLAs, the FDA has generally not accepted Type II DMF references for drug substance information. Lisa must include complete drug substance information directly in the BLA.​

Do’s and Don’ts

Do’s

Don’ts

FAQs

Can I submit Form 0356H on paper instead of electronically?
No. Since May 2017, NDAs, ANDAs, and BLAs must be submitted electronically via the FDA ESG in eCTD format. Paper submissions are no longer accepted for these application types.

Do I need Form 0356H for an annual report?
Yes. Annual reports submitted under 21 CFR 314.81(b)(2) require Form 0356H as a cover sheet. Select “Annual Report” in Field 21.

What happens if I list a facility not ready for inspection?
Yes, there is a penalty. FDA will set a goal date 15 months from submission and defer substantive review until the facility is inspection-ready.

Is Form 0356H required for Investigational New Drug (IND) applications?
No. INDs use Form FDA 1571, not Form 0356H. Form 0356H is only for marketing applications (NDA, ANDA, BLA).​

Can my U.S. Agent sign Form 0356H for a foreign applicant?
Yes. The authorized U.S. Agent named in Field 6 may sign in Field 37 or countersign in Field 38.​

Do orphan drug designations exempt me from user fees?
Yes. Applications for orphan-designated products are exempt from PDUFA application fees unless seeking approval for a non-rare disease indication.

What is the difference between FEI and DUNS numbers?
No, they are different. FEI (FDA Establishment Identifier) is assigned by FDA to identify facilities. DUNS is assigned by Dun & Bradstreet to identify business entities. Both are required on Form 0356H.

How long does FDA have to review my application?
Yes, there are timelines. Under PDUFA VII, FDA targets 10 months for standard reviews and 6 months for priority reviews. GDUFA III sets target dates based on priority status and inspection requirements.

Can I reference a Drug Master File (DMF) instead of including API information on Form 0356H?
Yes, for NDAs and ANDAs. List the DMF number and include a Letter of Authorization from the DMF holder. Note: BLAs generally cannot rely on Type II DMF references.

What if I discover an error after submission?
Yes, you can correct it. Submit an amendment with corrected Form 0356H. The original submission date may or may not be retained depending on the nature of the deficiency.​