An investigational new drug application is filed for testing the safety and effectiveness of a new chemical entity according to regulations. A new drug application seeks permission to market a new drug product and includes clinical trial results. An abbreviated new drug application allows generic drug manufacturers to file for approval using reference to an existing approved drug, without needing new clinical trials.

1. Investigational new drug (IND):
Investigational new drug (IND) deals with a new chemical entity, which will be tested for
obtaining evidence of safety and effectiveness in accordance with the regulations.
New drug application (NDA):
New drug application (NDA) is a document submitted to the regulatory authorities for
permission to market a new drug product in that country.
Abbreviated New Drug Application (ANDA):
Drug manufacturers must file an ANDA for approval to market a generic drug product. The
generic manufacturer is not required to perform clinical efficacy studies or nonclinical
toxicology studies for the ANDA.