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Abbreviated New Drug Applications and 505(b)(2) Applications OMB Control No. 09100786 IN: 0910AF97 SUPPORTING STATEMENT A. Justification 1. Circumstances Making the Collection of Information Necessary This

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What is abbreviated new drug applications?

Abbreviated New Drug Applications (ANDAs) are applications for generic drugs that demonstrate the drug is bioequivalent to a brand-name drug already approved by the FDA.

Who is required to file abbreviated new drug applications?

Any company looking to market a generic version of a brand-name drug is required to file an ANDA with the FDA.

How to fill out abbreviated new drug applications?

ANDAs must include scientific data and information about the drug's safety and effectiveness, as well as data demonstrating bioequivalence to the brand-name drug.

What is the purpose of abbreviated new drug applications?

The purpose of ANDAs is to streamline the approval process for generic drugs, making them more readily available and affordable for patients.

What information must be reported on abbreviated new drug applications?

ANDAs must include information on the drug's active ingredient, dosage form, strength, labeling, and bioequivalence data.

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