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This document pertains to the labeling and regulatory review for Advil Allergy and Congestion Relief, a combination drug product intended to treat symptoms associated with hay fever and upper respiratory
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What is NDA 22-113?
NDA 22-113 is a regulatory submission form required by the FDA for the approval of new drug applications, specifically for reporting certain safety and efficacy data.
Who is required to file NDA 22-113?
Pharmaceutical companies and sponsors seeking approval for new drugs are required to file NDA 22-113 as part of the drug approval process.
How to fill out NDA 22-113?
To fill out NDA 22-113, applicants must provide detailed information about the drug's formulation, manufacturing process, clinical trial results, labeling, and proposed indications.
What is the purpose of NDA 22-113?
The purpose of NDA 22-113 is to ensure that the FDA has sufficient information to evaluate the safety, effectiveness, and quality of a new drug before approval for commercial sale.
What information must be reported on NDA 22-113?
NDA 22-113 must report information including drug composition, clinical trial results, pharmacology, toxicology studies, manufacturing processes, and proposed labeling.
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