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Abbreviated New Drug Application (ANDA)

ANDA
Clinical

An FDA submission for approval of a generic drug product, demonstrating bioequivalence to the reference listed drug. Does not require full clinical trials since safety and efficacy are established.

उदाहरण

  • Paragraph IV certification
  • First-to-file 180-day exclusivity
  • BE studies 90% CI 80-125%

क्या आप जानते हैं?

An FDA submission for approval of a generic drug product, demonstrating bioequivalence to the reference listed drug. Does not require full clinical trials since safety and efficacy are established.