Fillable FDA Product Data Sheet: Biologics (Livingston)

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FDA Product Data Sheet: Biologics (Livingston)

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FDA: Biologics US Brokerage, 09/2015
FDA Product Data Sheet: Biologics
Account Number
Account Name
DUNS Number (if available)
Client Part Number*
Description of Product (as complete as possible)
Government Agency Processing Code
Tariff Number
FDA Product Code (if known)
Country of Origin**
FDA Country of Production**
Cargo Storage Status
Intended Use
Name of active ingredient(s) in prescription, over the counter, animal, drugs or medicated animal feeds:
* Part number as shown on Customs document to identify the product (item number, SKU, etc.)
** U.S. Customs considers the country of origin to be the country where the product last underwent a “substantial transformation” (resulting in an
increase in value.) The FDA considers the country of origin to be that of the actual manufacturer. Actual manufacturer is defined as the last party
involved in the production process.
FDA Actual Manufacturer
Company Name
City
State/Province
Zip/Postal Code
Country
DUNS Number (if available)
Manufacturer/Exporter Registration Numbers Provide registration numbers for all applicable
DA: New Drug, Abbreviated New Drug
PM#: Biologics Premarket Notification Number 501K
IND: Biologic Investigation New Drug Application Number
HRN: Biologic Cells, Tissues Product Establishment
Registration
STN: Biological Submission Tracking Number
BLN: Biologic License Number
Other:
FDA Shipper (As shown on Customs document, BOL or airway bill)
Company Name
City
State/Province
Zip/Postal Code
Country
DUNS Number (if available)
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FDA Product Data Sheet: Biologics (Livingston)

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Completed 23 September 2021

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