Determination That NUVIGIL (Armodafinil) Tablets, 100 Milligrams and 200 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness

الملخص

The Food and Drug Administration (FDA) has determined that NUVIGIL (armodafinil) Tablets, 100 milligrams (mg) and 200 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for armodafinil tablets, 100 mg and 200 mg, if all other legal and regulatory requirements are met.