"Promotional materials intended to be used in the first 120 days after approval that are submitted to FDA prior to dissemination/publication as required by 21 CFR 314.550 and 601.45.FDAeCTD " . . "FDA"^^ . "C97011"^^ . "Intellectual Product"^^ . . "Presubmission Accelerated Launch Material"^^ . "CL429567"^^ . . . "Presubmission Accelerated Launch Material"^^ . "Presubmission Accelerated LaunchPTFDA" . "Presubmission Accelerated Launch MaterialPTNCI" .