March 14, 2024

Patient Listening Session Summaries

FDA’s Patient Affairs is responsible for managing the Agency’s Patient Listening Session program. This page contains a list of all the Patient Listening Sessions that have been […]
March 14, 2024

Competitive Generic Therapy Approvals

  RLD Name and NDA Number ANDA Number ANDA Applicant Active Ingredient Name, Dosage Form, Strength  Date of Approval Eligible for CGT Exclusivity CGT Exclusivity Forfeiture […]
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