Application made to the FDA for a generic version of a branded drug. The duplicate drug must be bioequivalent to the branded version of the drug. The first company to receive FDA approval of an ANDA receives 180 days of market exclusivity for the generic drug. Compare with NDA.
Cheryl Abernathy and Bryan Sasbon, Quality Assurance Operations Manager, Ropack Pharma Solutions; QA Director & Regulatory Affairs, Ropack Pharma Solutions||September 8, 2016 Embracing the process as a means to a strong quality culture