1 |
Abbreviated New Drug ApplicationAn 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 [..]
|
<< Amylose | Active Pharmaceutical Ingredient >> |