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This document summarizes the regulatory details and exclusivity determination for the NDA application of Seroquel XR (quetiapine fumarate) submitted by AstraZeneca Pharmaceuticals, including various
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What is NDA 22-047?
NDA 22-047 refers to a New Drug Application submitted to the FDA for the approval of a new pharmaceutical product.
Who is required to file NDA 22-047?
Typically, the sponsor or manufacturer of the drug, which can be a pharmaceutical company or organization intending to market the drug, is required to file NDA 22-047.
How to fill out NDA 22-047?
To fill out NDA 22-047, the applicant must provide comprehensive data on the drug's safety, efficacy, manufacturing processes, labeling, and proposed usage, following FDA guidelines and formats.
What is the purpose of NDA 22-047?
The purpose of NDA 22-047 is to seek approval from the FDA to market a new drug in the United States, ensuring it is safe and effective for public use.
What information must be reported on NDA 22-047?
The NDA 22-047 must report information including drug formulation, clinical trial results, pharmacological data, labeling information, and manufacturing details.
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