Innovator Multiple Source Drug Law and Legal Definition

The term "innovator multiple source drug" means a multiple source drug that was originally marketed under an original new drug application approved by the Food and Drug Administration [42 USCS § 1396r-8(k)(7)(A) (ii)].

Innovator multiple source drugs include all Covered Outpatient Drugs approved under a New Drug Application (NDA), Product License Approval (PLA), Establishment License Approval (ELA) or Antibiotic Drug Approval (ADA).