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Reference ID 3124665 - accessdata fda

Reference ID 3124665 - accessdata fda 2025

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The document is a series of communications regarding the New Drug Application (NDA) 202543 for Levetiracetam Injection submitted by H Q Specialty Pharma Corporation. It includes correspondence between FDA officials and the applicant discussing labeling requirements, regulatory compliance, and issues related to bioanalytical studies conducted by Cetero Research. The FDA has identified significant violations in these studies that raise concerns about the reliability of the data submitted. The document outlines specific requests for revisions and additional information needed to continue the evaluation of the NDA.

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Begin by reviewing the application number and ensure you have all necessary information at hand. This includes details about the drug product, such as its name and dosage.
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A registered facility receives a unique registration number from FDA which FDA uses to identify the firm for inspections, exams, screening of imported products, and other activities.

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FDA registration number is a unique identifier assigned by the US Food and Drug Administration (FDA) to facilities that manufacture, process, pack, or store food, drugs, medical devices, or cosmetics intended for consumption or use in the United States.

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Domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA. Domestic and foreign drug manufacturers, repackers or re-labelers are also required to list all of their commercially marketed drug products.

What is a FDA ID?

The U.S. FDA Unique Device Identification (UDI) Rule* establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device.

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Look up the drug or biological product in Drugs @ FDA. Most FDA-approved human drugs and therapeutic biological products are listed in Drugs @ FDA, a searchable database. The database allows you to search by drug name, active ingredient, or application (NDA, ANDA, or BLA) number.

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A reference number assigned by FDA to a facility registration for purposes of confirming a Notification of Registration. If your registration number and PIN were sent to you by mail you were also sent a receipt code to send back to FDA to confirm that you received the information.

Reference ID 3124665 - accessdata fda 2025

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