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Pharmacology Template HISTORY OR BACKGROUND OF THE DRUG Please include: any interesting development/business angles patent interests, date of FDA approval (and approval in other countries, if this

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What is abbreviated new drug application?

Abbreviated New Drug Application (ANDA) is a regulatory submission to FDA for the approval of generic drugs.

Who is required to file abbreviated new drug application?

Manufacturers seeking approval to market generic drugs are required to file ANDA.

How to fill out abbreviated new drug application?

ANDA can be filled out electronically through FDA's Electronic Submissions Gateway.

What is the purpose of abbreviated new drug application?

The purpose of ANDA is to demonstrate bioequivalence to the existing brand-name drug and obtain approval for marketing generic version.

What information must be reported on abbreviated new drug application?

ANDA must include information on drug formulation, manufacturing process, labeling, and bioequivalence data.

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