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

FDA Form 0356v serves as the gateway document for any paper-based submission seeking approval of a new animal drug under Sections 512 and 571 of the Federal Food, Drug, and Cosmetic Act. This six-page form collects applicant information, product descriptions, and submission classifications that FDA’s Center for Veterinary Medicine (CVM) needs to properly route and review your application.

Under 21 CFR Part 514, pharmaceutical companies cannot market any new animal drug without an approved New Animal Drug Application (NADA), Abbreviated NADA (ANADA), or Conditional NADA (CNADA). In fiscal year 2025, FDA set full application fees at $581,735 for original NADAs and $161,907 for generic ANADAs—making errors on Form 0356v extremely costly when they trigger delays or refusals.

Here’s what you’ll learn in this guide:

📋 Every field and checkbox explained with real-world completion examples for NADAs, ANADAs, and supplements

⚠️ The specific deficiencies that cause CVM to refuse-to-file or refuse-to-review your submission

💰 User fee requirements and how to properly attach Form FDA 3546 for ADUFA/AGDUFA compliance

📝 Paper vs. electronic submission rules and when Form 0356v is actually required

✅ Do’s, don’ts, and common mistakes that delay approvals by months or years

What Is Form FDA 0356v and When Do You Need It?

Form FDA 0356v is officially titled “Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval).” The form accompanies every paper submission relating to veterinary drug approval—this includes original applications, supplements, amendments, reactivations, and Minor Changes and Stability Reports (MCSRs).​

Critical Distinction: Paper vs. Electronic Submissions

Form 0356v is only required for paper submissions. If you submit electronically through FDA’s eSubmitter program, the form is not required because eSubmitter templates capture the same information electronically.

All animal drug sponsors must now use eSubmitter for submissions to CVM’s Office of New Animal Product Evaluation (ONAPE) and Office of Generic Animal Drugs (OGAD). This means Form 0356v is primarily relevant for legacy paper submissions or specific circumstances where electronic submission isn’t feasible.​

The Three Types of New Animal Drug Applications

Before completing Form 0356v, you must understand which application pathway applies to your drug product.

New Animal Drug Application (NADA)

A NADA seeks approval of a new animal drug. This pathway requires comprehensive safety and effectiveness data across seven technical sections: identification, chemistry/manufacturing/controls (CMC), human food safety (if applicable), target animal safety, effectiveness, environmental impact, and labeling.​

Abbreviated NADA (ANADA)

An ANADA seeks approval of a generic copy of an already-approved new animal drug. Instead of conducting full safety and effectiveness studies, ANADA sponsors demonstrate bioequivalence to the Reference Listed New Animal Drug (RLNAD). The ANADA pathway has six technical sections: bioequivalence, patent certification, CMC, environmental impact, labeling, and human food safety (if applicable).

Conditional NADA (CNADA)

A CNADA seeks conditional approval for a drug that demonstrates safety but only a “reasonable expectation of effectiveness” rather than “substantial evidence.” This pathway allows marketing for up to five years while collecting additional effectiveness data—provided FDA approves annual renewal requests.​

Section-by-Section Guide: Completing Form 0356v

The form spans six pages. Pages 1–3 require completion and signature; pages 4–6 contain instructions. Always submit three identical copies of your submission with a copy of Form 0356v accompanying each copy.​

Page 1: Application Information and Applicant Details

Application or Investigational File Number
Enter your assigned INAD, JINAD, NADA, or ANADA number. For original applications where no number exists yet, leave blank—FDA assigns the number upon receipt.

Date of Submission
Enter the date matching your cover letter. This date triggers user fee payment deadlines and review clock calculations.

Applicant Information Section
Provide the legal entity name, complete mailing address, telephone, and fax numbers. International applicants require special attention: if you do not reside or have a place of business within the United States, you must designate a U.S. agent who is a permanent U.S. resident. This agent must also sign the application.​

Product Description Section
Complete all fields that identify your drug product:

• Established Name: The generic or proper name (e.g., amoxicillin trihydrate)
• Proprietary Name: The trade name, if any
• Dosage Form: Tablet, injectable, powder, etc.
• Dose or Dose Range: Reflect the dose of the form actually administered to animals​
• Route(s) of Administration: Oral, parenteral, topical, etc.
• Species and Class: Target animal species (e.g., “cattle, swine” or “dogs, cats”)

Example Scenario: Maria’s Generic Injectable
Maria works for a generic drug manufacturer submitting an ANADA for an injectable antibiotic for cattle. She enters:

• Established Name: Florfenicol
• Dosage Form: Injectable solution
• Dose Range: 20 mg/kg body weight
• Route: Subcutaneous
• Species: Cattle (beef and non-lactating dairy)

Page 1: Marketing Status and Indication

Proposed Marketing Status
Select one checkbox:

Designated New Animal Drug Status
Check “Yes” if your drug received Minor Use/Minor Species (MUMS) designation under Section 573(a) of the FD&C Act. MUMS designation provides incentives including user fee waivers, extended marketing exclusivity, and eligibility for conditional approval.​

Proposed Indication(s) for Use
State the specific therapeutic claim. Be precise—vague indications trigger review delays.

Page 1–2: Application Description

Type of Application
Check one box if submitting an application:

• NADA: For new drugs requiring full safety/effectiveness data
• ANADA: For generic copies—must also identify the Reference Listed Drug (RLD) including proprietary name, application number, and holder name
• Application for Conditional Approval: For drugs meeting “reasonable expectation” standard

Check “Administrative Application” if you’re filing based on previously completed technical section reviews—submit your Freedom of Information technical section complete letter.​

Type of Submission
Check the box describing your submission’s purpose:

CMC Supplement Categories Explained

The Chemistry, Manufacturing, and Controls categories reflect risk levels and regulatory requirements under 21 CFR §514.8:

Page 2: Submission Content Checklist

This checklist indicates what technical sections your submission contains. Check each applicable box.

For NADAs and Conditional Approval Applications (Items 1–8):

1. Identification [21 CFR §514.1(b)(1)]: Drug identity information
2. Table of Contents and Summary [21 CFR §514.1(b)(2)]: Comprehensive index required
3. Technical Sections:
   • Labeling: Check either “Draft (facsimile)” or “Final printed”
   • Chemistry, Manufacturing, and Controls: Drug substance and product specifications
   • Human Food Safety: Required for food-producing animals
   • Target Animal Safety (TAS): Safety in intended species
   • Effectiveness: Check “Substantial evidence” (NADA) or “Reasonable expectation” (CNADA)
   • Environmental Impact: Either categorical exclusion claim or environmental assessment
   • All Other Information: Additional supporting data
   • Freedom of Information Summary: Public summary per 21 CFR §514.11
4. Samples: Submit only when FDA requests
5. VFD Copies: Required for Veterinary Feed Directive drugs​
6. Commitments: Labeling/advertising, shipping, GMP, and GLP compliance statements
7. Patent Information: Any patents claiming the drug or methods of use
8. User Fee Cover Sheet (Form FDA 3546): Required for fee-subject applications​

For ANADAs (Items 9–11):

9. Identification
10. Table of Contents and Summary
11. Technical Sections:
    • Withdrawal Period Information: Required residue data
    • Bioequivalence: Either waiver request or study data
    • Labeling: Draft or final
    • Chemistry, Manufacturing, and Controls
    • Patent Certification: Required certification under Section 512(n)(1)(H)
    • Environmental Impact
    • Freedom of Information Summary

Page 2: Description of Submission and Cross References

Number of Volumes Submitted
Enter the total volume count. Complex applications may span multiple binders.

Description of Electronic Media
Describe any CDs, DVDs, or electronic files accompanying the paper submission.

Cross References
List all investigational files (INADs, JINADs), applications (NADAs, ANADAs), and master files (VMFs, DMFs, PMFs) referenced in your submission. Include right-of-reference authorizations for any files you don’t own.​

Page 3: Certifications and Signatures

Certifications
By signing, you certify:

• Personal review of submission (or assurance from qualified personnel)
• All copies are identical
• Referenced information is believed true, accurate, and complete
• No debarred persons were involved [Section 306(a) or (b) of FD&C Act]
• Awareness of penalties for false information (18 U.S.C. § 1001)

Post-Approval Agreements
If approved, you agree to:

• Submit safety update reports as requested
• Comply with all applicable statutes and regulations
• Wait for DEA scheduling (if applicable for controlled substances)
• Notify FDA of any changes to approval conditions

Signature Requirements

Common Mistakes to Avoid

FDA’s refuse-to-file and refuse-to-review policies under 21 CFR 514.110 provide specific grounds for rejection. Avoid these errors:

Administrative Errors

Technical Section Deficiencies

CVM will refuse to review submissions where the “number or type of errors cause the quality of the entire submission to be questioned.”

Environmental Assessment Mistakes

Under 21 CFR 25.15, every application must include either an environmental assessment (EA) or categorical exclusion (CE) claim. The CE claim must cite the specific exclusion category and state that “no extraordinary circumstances exist.”​

Do’s and Don’ts

Do’s

✅ Do submit three identical copies with Form 0356v accompanying each copy​

✅ Do place the form before the cover letter, table of contents, and submission content

✅ Do fully describe the submission in your cover letter—especially for supplements, explain the change you’re seeking

✅ Do include comprehensive table of contents with sequential page numbering and each section beginning on a new page

✅ Do verify user fee requirements before submission—attach Form FDA 3546 if fees apply​

Don’ts

❌ Don’t check multiple boxes under “Type of Application”—select only one

❌ Don’t leave fields blank assuming CVM will fill them—missing information triggers delays

❌ Don’t submit investigational file data without first establishing the INAD/JINAD file

❌ Don’t reference master files without valid right-of-reference authorization

❌ Don’t submit incomplete environmental documentation—this is a specific RTF criterion​

User Fee Requirements

ADUFA Fees (New Animal Drugs)

The Animal Drug User Fee Act requires fees for NADAs and supplements.​

AGDUFA Fees (Generic Animal Drugs)

The Animal Generic Drug User Fee Act covers ANADAs.​

Fee Waivers

MUMS-designated drugs may qualify for user fee waivers if intended solely for minor use or minor species indications. Submit waiver requests at least 60 days before the application due date.

Three Real-World Scenarios

Scenario 1: Original NADA for Cattle Antibiotic

Situation: PharmaCo develops a new antibiotic for bovine respiratory disease in cattle.

Scenario 2: ANADA for Generic Dog Pain Medication

Situation: GenericVet seeks approval for a generic copy of an approved NSAID for dogs.

Scenario 3: CMC Prior Approval Supplement

Situation: ApprovedDrug Inc. changes manufacturing sites for an approved injectable.

Submission Address and Formatting Requirements

For paper submissions, send to:

Document Control Unit (HFV-199)
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855​

Formatting Requirements:

• Place applicant name/address and proprietary/established names on front cover
• Begin each section on new page
• Sequentially number all pages
• Include comprehensive table of contents per 21 CFR §514.1(b)(2)

FAQs

Is Form 0356v required for electronic submissions through eSubmitter?
No. Form 0356v is only required for paper submissions. The eSubmitter templates capture equivalent information electronically.​

Can I submit a NADA without establishing an INAD file first?
No. Sponsors must establish an investigational file and meet exemption requirements under 21 CFR 511.1 before shipping investigational drugs for clinical investigations.​

Do I need a U.S. agent if my company has a U.S. subsidiary?
No. A U.S. agent is only required if neither you nor your authorized representative resides or has a place of business within the United States.​

Are user fees required for Minor Use/Minor Species drugs?
No. Sponsors of MUMS-designated drugs may apply for fee waivers if the drug is intended solely for minor use or minor species indications.​

Can I market my drug under a CBE supplement before FDA approval?
Yes. For CBE-Immediate supplements, distribution may begin upon FDA receipt. For CBE-30 supplements, distribution may begin 30 days after receipt unless FDA objects.​

What happens if FDA refuses to file my application?
Your application is returned. FDA must notify you of refusal reasons within 30 days under 21 CFR 514.110(c). You may request a meeting to discuss deficiencies or file “over protest.”​

How long does CVM have to review my INAD submission?
60 days. Within 60 days of receipt, CVM will refuse to review submissions determined insufficient or of unacceptable quality upon initial inspection.

Must I include patent certification in every ANADA?
Yes. Section 512(n)(1)(H) of the FD&C Act requires patent certification for generic animal drugs.​

Can I reference another company’s master file?
Yes. Include a copy of your right-of-reference authorization in your submission or confirm it was previously submitted to the referenced file.​

Is environmental assessment always required?
No. Most FDA CVM actions qualify for categorical exclusion under 21 CFR 25.30 or 25.33. You must claim the specific exclusion and certify no extraordinary circumstances exist.​