FDA Drug Listing Form

Complete this form to submit your FDA drug product listing. LMG will review your details and contact you within 1 business day.

21 CFR Part 207 SPL Submission Fixed Price — USD 399 Since 2009

Description of Services & Cost

Services	Fees	Total Fees
Drug ListingPer drug product — SPL preparation & FDA submission	USD 399	$0
Label ReviewPer drug product label	USD 649	$0
Total		$0

All fees are in USD. Fixed price — no hourly fees or hidden charges. Work commences upon receipt of payment.

Manufacturing Establishment Information

Add all establishments involved in manufacturing this drug product. At least one establishment is required.

Establishment 1 *

Establishment Name * Required.

DUNS Number (if available)

FDA Registration Number (if available)

Type of Activity * Required.

Address

City

State (if applicable)

Country

Drug Product Information

Proprietary Name (Brand Name) * Required.

Proprietary Name Suffix (if applicable)

Non-Proprietary Name (Generic Name) * Required.

Intended Use of the Drug * Required.

Route of Administration * Required.

Please describe the route of administration

Dosage Form * Required.

Marketing Category * Required.

Please describe the marketing category

OTC Monograph Number (if OTC Monograph)

Required if marketing category is OTC Monograph.

Application Number (NDA/ANDA/BLA/NADA/ANADA/MIF number)

Marketing Start Date * Required.

Quantity / Net Weight * Required.

Product NDC (if already assigned)

Package Information

Enter inner and outer package details. The Labeler Code is 10 digits (including the product and package codes).

Inner Package

Inner Package Type (if applicable)

Inner Package Quantity (if applicable)

Inner Labeler Code (10 digits)

Outer Package

Outer Package Type * Required.

Outer Package Quantity * Required.

Outer Labeler Code (10 digits)

Additional Package Sizes (if applicable)

DEA Schedule (if applicable)

Not a controlled substance

Characteristics

Flavor(if applicable)

Color *(mandatory for solid dosage forms) Required for solid dosage forms.

Shape *(required for solid dosage forms) Required for solid dosage forms.

Scoring *(required for solid dosage forms)

Indicates whether the solid dosage form has score lines to aid in splitting.

Required for solid dosage forms.

Imprint Information *(required for solid dosage forms)

Enter any text, numbers, or symbols physically printed or embossed on the solid dosage form (e.g. LMG 100).

Required for solid dosage forms.

Size *(required for solid dosage forms)

Longest single dimension in mm (e.g. 12)

Required for solid dosage forms.

Active Ingredients

List all active ingredients. Include strength per unit dose/percentage and UNII code if known. The first active ingredient is required.

Active Ingredient 1

Ingredient Name *Required.

Strength *

UNII (if known)

Active Ingredient 2

Ingredient Name

Strength

UNII (if known)

Active Ingredient 3

Ingredient Name

Strength

UNII (if known)

Inactive Ingredients (Excipients)

List all inactive ingredients. Strength is optional. UNII code is recommended where known. The first click loads 10 rows; click again to add more.

Other Information

Additional Information (if any)

Label Images (upload — you can select multiple files)

You can select multiple files at once — hold Ctrl (Windows) or Cmd (Mac) to select more than one. Include inner label, outer label, kit labels, and any other relevant label files. Accepted formats: JPG, PNG, PDF, TIFF. Maximum 5 MB per file. If you have additional labels after submission, email them to info@fdahelp.us with your reference number.

Submitter Information

Submitter Name * Required.

Job Title * Required.

Submitter Email * Valid email required.

Alternate Email Address (optional)

Agreement

Terms and Conditions — FDA Drug Listing

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We appreciate your decision to select Liberty Management Group Ltd. ("LMG") to prepare and submit your FDA drug product listing as required by 21 CFR Part 207. This Agreement describes the scope of our relationship with your company. By submitting the requested listing information to LMG, your company agrees to be bound by the terms and conditions listed in this document.

1. Services Provided

Our services will be limited to preparing and submitting the SPL (Structured Product Labeling) file required for FDA drug product listing under 21 CFR Part 207. The services include preparation of the drug listing SPL, product image submission where applicable, and submission via the FDA Electronic Submissions Gateway (ESG). On all submissions, "Liberty Management Group Ltd." will be identified as the "Official Correspondent" for your company. You understand and agree that the information your company provides to LMG will be used for the purpose of completing a public filing with the United States Government.

2. Client Information

You agree and warrant that all information your company provides to LMG, including but not limited to product name, ingredients, labeling, and packaging information (collectively, "Client Information"), is correct and truthful to the best of your knowledge. You understand and acknowledge that LMG will rely upon the Client Information your company provides. You further agree and warrant that you will promptly inform LMG of any changes in the Client Information that are required to be updated with the FDA, in accordance with the biannual update requirements of June and December each year.

3. Termination Notices

Either party may terminate the relationship at any time for any reason by providing five (5) days' prior written notice to the other party. In the event of termination of this Agreement by either party, LMG shall not be liable to your company for any reimbursement or damages on account of the loss of prospective or actual sales or profits of your company, or for your company's expenditures, inventory, investments, leases, or commitments connected with the business or goodwill of your company. In no event shall LMG's liability exceed the amount of the fees paid by your company to LMG in any given calendar year.

4. Limitations

LMG shall not be liable for any delay in performing its obligations under this Agreement if such delay is caused by circumstances beyond LMG's reasonable control.

5. Governing Law and Venue

This Agreement and the interpretation of its terms shall be governed and construed in accordance with the laws of the State of Illinois, U.S.A., without regard to its conflicts of laws rules. The parties consent to the sole and exclusive jurisdiction and venue of the Illinois courts in Will County, Illinois, U.S.A.

Yes, I agree to the above Terms and Conditions. I confirm that all information is accurate and I am authorized to submit this application on behalf of the labeler.

After submission, LMG will review your application and contact you within 1 business day.

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Drug Listing Submitted Successfully

Thank you. LMG has received your FDA Drug Listing application. Our team will review your submission and contact you within 1 business day.

Important: Please email your label image to info@fdahelp.us with your reference number in the subject line.

Your reference number

Important — PayPal Payment Instructions

When making your payment via PayPal, please include your reference number in the payment note / message to seller field. This helps LMG match your payment to your application instantly.

Proceed to Payment Portal

Work begins upon receipt of payment.

Questions? info@fdahelp.us | +1 (630) 270-2921