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This document outlines the commitments and regulatory requirements related to the postmarketing study for Cialis (tadalafil), including the timeline for study initiation and submission of promotional
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What is NDA 21-368?
NDA 21-368 is a New Drug Application submitted to the FDA for the approval of a new pharmaceutical product.
Who is required to file NDA 21-368?
The sponsor or manufacturer of the new drug is required to file NDA 21-368.
How to fill out NDA 21-368?
To fill out NDA 21-368, applicants must provide detailed information about the drug's clinical trials, manufacturing process, labeling, and proposed usage, following FDA guidelines.
What is the purpose of NDA 21-368?
The purpose of NDA 21-368 is to seek FDA approval for a new drug to ensure its safety, efficacy, and quality for public use.
What information must be reported on NDA 21-368?
NDA 21-368 must report data including the drug's chemical composition, pharmacological effects, clinical study results, proposed labeling, and manufacturing practices.
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