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CHAPTERIIABBREVIATED NEW DRUG APPLICATION (AND)by: j. Jayapura lecturer department of pharmacy practice SRM college of pharmacy SRM universityABBREVIATED NEW DRUG APPLICATION INTRODUCTION AND Ais

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What is abbreviated new?

Abbreviated New Drug Application (ANDA) is a generic drug application for an existing licensed medication.

Who is required to file abbreviated new?

Any company wanting to market a generic version of a brand-name medication.

How to fill out abbreviated new?

The application must include bioequivalence data and quality control information.

What is the purpose of abbreviated new?

To demonstrate that the generic drug is equivalent to the brand-name drug in terms of safety and efficacy.

What information must be reported on abbreviated new?

Detailed formulation, manufacturing process, stability data, etc.

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