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This document provides an exclusivity determination for Isopto Carpine, including the review of clinical data and summary of exclusivity requests.
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What is NDA 200-890?
NDA 200-890 is a specific regulatory submission form used by pharmaceutical companies to report data related to the safety and efficacy of new drugs to the FDA.
Who is required to file NDA 200-890?
Pharmaceutical manufacturers or sponsors seeking approval for new drug applications are required to file NDA 200-890.
How to fill out NDA 200-890?
Filling out NDA 200-890 involves providing detailed information about the drug, such as its active ingredients, clinical study data, labeling, and proposed manufacturing processes, following the FDA's guidelines for submission.
What is the purpose of NDA 200-890?
The purpose of NDA 200-890 is to evaluate the safety and effectiveness of a new drug before it can be marketed to the public.
What information must be reported on NDA 200-890?
Information that must be reported on NDA 200-890 includes clinical trial results, pharmacology, toxicology, manufacturing details, labeling information, and any other data required by the FDA to assess the drug.
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