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).
Legal Definition list
Related Legal Terms
- Abbreviated Drug Application
- Abbreviated New Drug Applications [ANDA]
- Acceptable Medical Source
- Accidental Radiation Occurrence [Food and Drugs]
- Accountable Sealed Radioactive Source
- Addictive Drug
- Adverse Drug Experience
- Aging and Disability Resource Center
- Agricultural Nonpoint Source Pollution
- Agricultural Resource