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Reference ID 3124665 - accessdata fda

Reference ID 3124665 - accessdata fda 2025

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The document pertains to 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 regarding labeling requirements, regulatory compliance, and issues related to bioanalytical studies conducted by Cetero Research. The FDA outlines necessary revisions to labeling, requests additional data on drug stability and compatibility, and addresses concerns about the validity of data from previous studies. The application is under review with a user fee goal date set for November 13, 2011.

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0:31 1:40 How Do I Find My FDA Food Facility Registration Number? - YouTube YouTube Start of suggested clip End of suggested clip You can contact the FDA directly for assistance. Theyre pretty helpful folks over there. RememberMoreYou can contact the FDA directly for assistance. Theyre pretty helpful folks over there. Remember this number is essential for compliance with the fdas regulations.

What is the FEI number identifier?

An FDA Establishment Identifier or Firm Establishment Identifier (FEI) is an FDA system-generated number used to identify a firm. The FDA systems interact, occasionally creating multiple records (FEIs) for one firm. Upon evaluation, these numbers are merged into one surviving FEI, which is used to identify the firm.

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3. FDA Drug Establishment Registration Search Click on the below link. . Enter the company name in query box. FDA Drug Establishment Search. After you perform search action , name of the establishment, address and validity of the registration will appear.

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If your firm does not have an FEI number assigned by FDA, please send a request to feiportal@fda.hhs.gov. Applicants should ensure that their establishment has a current and valid s Food Facility Registration.

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Facility FEI Number. The Facility FEI (FDA Establishment Identifier) Number data element is a number assigned by the FDA for tracking inspections.

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The FDA registration number is a crucial requirement for any company seeking to market and sell its products in the US. This unique identifier provides confidence of legitimacy, credibility, and compliance to the industry, ensuring that the products meet the strict safety and quality standards set by the FDA.

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An FDA product code describes a specific product and contains a combination of five to seven numbers and letters. The product code submitted with each FDA line item should match the actual product name and/or invoice description of the product.

Reference ID 3124665 - accessdata fda 2025

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