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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:212728Orig1s000 PRODUCT QUALITY REVIEW(S)RECOMMENDATION: Approval 212728 Review 1 Drug Product Name Dosage Form Strength Route of Administration
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The US agent is a designated individual or entity authorized to accept legal documents on behalf of a foreign entity operating in the United States.
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Foreign entities operating in the United States are required to appoint a US agent and file their information with the appropriate authorities.
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To fill out the US agent designation, the foreign entity must provide the US agent's contact information, including name, address, and phone number, along with their own entity details.
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The US agent serves as a point of contact for legal matters and official communications for the foreign entity operating in the United States.
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The US agent designation form typically requires the US agent's contact information and details about the foreign entity, such as name, address, and nature of business.
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