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This document discusses the evaluation and approval process for the drug Dyloject (diclofenac sodium) Injection, including safety studies, labeling comments, and pediatric studies.
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What is nda 022396?
NDA 022396 refers to a New Drug Application submitted to the FDA for regulatory approval of a specific drug product.
Who is required to file nda 022396?
The sponsor or manufacturer of the drug is required to file NDA 022396 for regulatory approval.
How to fill out nda 022396?
To fill out NDA 022396, the applicant must complete the required forms, provide comprehensive data including clinical trial results, manufacturing information, and labeling, and submit it electronically to the FDA.
What is the purpose of nda 022396?
The purpose of NDA 022396 is to seek approval from the FDA to market a new drug product based on its safety, efficacy, and manufacturing quality.
What information must be reported on nda 022396?
NDA 022396 must report information including the drug's chemical composition, clinical trial data, proposed labeling, pharmacology, and manufacturing details.
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