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TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT 13. SIGNATURE 12. APPLICANT S RETURN ADDRESS Name of Sponsor / Applicant / Submitter Sign FDA USE ONLY NDA OR ANDA NUMBER Address 1 DATE OF RECEIPT City FORM FDA 2252 12/14 State Previous Edition Is Obsolete ZIP or Postal Code Page 1 of 2 PSC Publishing Services 301 443-6740 EF This section applies only to requirements of the Paperwork Reduction Act of 1995. DATE SUBMITTED TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE...
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How to fill out fda form 2252

How to fill out fda 2252 form?
01
Collect all the necessary information and documents required for the form, such as the product details, manufacturing process, and ingredient list.
02
Fill in the form accurately and completely, providing all the requested information, including any specific details or attachments required by the FDA.
03
Double-check the form for any errors or missing information before submitting it to ensure its accuracy and completeness.
04
Submit the filled-out FDA 2252 form to the appropriate FDA office or online portal as per their guidelines and instructions.
Who needs fda 2252 form?
01
Manufacturers and importers of food products or beverages that contain added caffeine need to fill out the FDA 2252 form.
02
Food establishments or businesses that produce, distribute, or import products with added caffeine are also required to complete this form.
03
Compliance officers, regulatory agencies, or any entity responsible for enforcing food safety regulations may request the FDA 2252 form.
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What is fda form 2252?
FDA Form 2252 is a form used for the registration of pharmaceutical companies, which includes information about the company and its products.
Who is required to file fda form 2252?
Pharmaceutical manufacturers, repackagers, and relabelers are required to file FDA Form 2252.
How to fill out fda form 2252?
To fill out FDA Form 2252, one must provide company identification details, specifics about the products being registered, and certify compliance with regulatory requirements.
What is the purpose of fda form 2252?
The purpose of FDA Form 2252 is to ensure proper registration of pharmaceutical companies and their products with the FDA for regulatory oversight.
What information must be reported on fda form 2252?
FDA Form 2252 requires information such as the name and address of the firm, the names of the drugs, and the types of operations (manufacturing, repackaging, or relabeling) being performed.
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