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Innovator Multiple Source Drug

relevant to both Medicaid and Medicare outpatient prescriptions drug coverage reimbursement, this classification of a drug is defined as all Covered Outpatient Drugs approved under a New Drug Application (NDA), Product License Approval (PLA), Establishment License Approval (ELA) or Antibiotic Drug Approval (ADA). A Covered Outpatient Drug marketed by a cross-licensed producer or distributor under the approved NDA is included as an innovator multiple source drug when the drug product meets this definition. An Innovator Multiple Source drug also includes an authorized generic drug including any labelers operating under the NDA. See Generic Drug in this Glossary.

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