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This document pertains to the New Drug Application (NDA) for a drug product comprised of sodium phosphate monobasic monohydrate and sodium phosphate dibasic anhydrous, intended for use in cleansing
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How to fill out NDA 21-892
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Obtain the NDA 21-892 form from the relevant authority or website.
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Fill out the 'Applicant Information' section with accurate details.
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Provide any required personal information, including name, address, and contact details.
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If applicable, list any additional parties that need to sign the NDA.
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What is NDA 21-892?
NDA 21-892 is a specific form used by pharmaceutical companies to request approval from the FDA for new drugs or drug formulations.
Who is required to file NDA 21-892?
Manufacturers or sponsors who want to market a new drug or make changes to an existing drug's formulation are required to file NDA 21-892.
How to fill out NDA 21-892?
To fill out NDA 21-892, applicants must provide detailed information about the drug, including its composition, manufacturing processes, labeling, and clinical study results, in accordance with FDA guidelines.
What is the purpose of NDA 21-892?
The purpose of NDA 21-892 is to evaluate the safety and efficacy of new drugs before they can be marketed to the public.
What information must be reported on NDA 21-892?
Information that must be reported on NDA 21-892 includes drug substance details, formulation composition, manufacturing methods, clinical trial data, proposed labeling, and any previous applications or reviews.
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