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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:AND 091363Orig1s000APPROVAL LETTERDEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration Silver Spring, MD 20993ANDA 091363Dr.

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What is anda 091363orig1s000?

anda 091363orig1s000 is a form used for filing a specific type of application with the FDA.

Who is required to file anda 091363orig1s000?

Manufacturers of pharmaceutical products are required to file anda 091363orig1s000 if they wish to market their product in the United States.

How to fill out anda 091363orig1s000?

To fill out anda 091363orig1s000, manufacturers must provide detailed information about the product, its manufacturing process, and any clinical studies conducted.

What is the purpose of anda 091363orig1s000?

The purpose of anda 091363orig1s000 is to demonstrate to the FDA that a generic drug is equivalent to a brand-name drug in terms of safety and effectiveness.

What information must be reported on anda 091363orig1s000?

Information such as the composition of the drug, its manufacturing process, and any clinical data must be reported on anda 091363orig1s000.

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