. . . "FDA"^^ . "C97012"^^ . . "Presubmission Accelerated Non-Launch MaterialPTNCI" . "Presubmission Accelerated Non-launchPTFDA" . "Presubmission Accelerated Non-Launch Material"^^ . "Intellectual Product"^^ . "Promotional materials intended to be used after the 120 day post-approval period that are submitted to FDA prior to dissemination/publication as required by 21 CFR 314.550 and 601.45.FDAeCTD " . "Presubmission Accelerated Non-Launch Material"^^ . "CL429568"^^ .