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This document provides a detailed review of the clinical pharmacology and biopharmaceutics aspects for the NDA 202343 submission regarding the fixed-dose combination of sitagliptin and simvastatin.
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What is NDA 202343?
NDA 202343 is a New Drug Application submitted to the U.S. Food and Drug Administration for the approval of a new pharmaceutical product.
Who is required to file NDA 202343?
The manufacturer or sponsor of the new drug must file NDA 202343 to seek approval for marketing the product.
How to fill out NDA 202343?
To fill out NDA 202343, applicants must complete the required forms, provide detailed information about clinical trials, safety, efficacy, manufacturing processes, and labeling, and submit the application to the FDA.
What is the purpose of NDA 202343?
The purpose of NDA 202343 is to obtain FDA approval for a new drug to ensure it is safe and effective for public use before it can be marketed.
What information must be reported on NDA 202343?
NDA 202343 must report information including drug composition, manufacturing methods, study results, safety data, labeling, and proposed use indications.
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