Meaning Abbreviated New Drug Application
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Abbreviated New Drug Application


An application to market a generic drug in the USA. The application does not contain extensive preclinical (pharmacology & toxicology) or clinical data. Instead an ANDA for a typical tablet or capsule relies on therapeutic equivalence to the innovator product (or reference listed product), together with an extensive CMC section. Please click he [..]
Source: dfepharma.com (offline)




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