Abbreviated New Drug Application (ANDA)

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Abbreviated New Drug Application (ANDA)

Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval (for an existing licensed approved drug). The ANDA is submitted to the office of Generic drugs, US. After a review of the documents, USFDA gives approval as generic drugs.

After approval, an applicant may manufacture and market the generic drug product to the US market. A generic drug product is one that is similar to branded drug product in dosage form, strength, and route of administration, quality, performance characteristics, and intended use.

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