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ANDA Submission and GDUFA Guidance 2025
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(0 reseñas)lunes, 28 de marzo de 2022 (1 día), United States, United States
Descripción general
Fecha: 28 de mar de 2022 (1 día)
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An ANDA is an Abbreviated New Drug Application. This application is submitted to the FDA to seek approval to produce a U.S. generic drug from an existing patented approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs. After approval, the applicant is able to produce and market the generic drug product.
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