SubmissionClassCodeID SubmissionClassCode SubmissionClassCodeDescription 1 BIOEQUIV Bioequivalence 2 EFFICACY Efficacy 3 LABELING Labeling 4 MANUF (CMC) Manufacturing (CMC) 5 N/A Not Applicable 6 S Supplement 7 TYPE 1 Type 1 - New Molecular Entity 8 TYPE 1/4 Type 1 - New Molecular Entity and Type 4 - New Combination 9 TYPE 2 Type 2 - New Active Ingredient 10 TYPE 2/3 Type 2 - New Active Ingredient and Type 3 - New Dosage Form 11 TYPE 2/4 Type 2 New Active Ingredient and Type 4 New Combination 12 TYPE 3 Type 3 - New Dosage Form 13 TYPE 3/4 Type 3 - New Dosage Form and Type 4 - New Combination 14 TYPE 4 Type 4 - New Combination 15 TYPE 5 Type 5 - New Formulation or New Manufacturer 16 TYPE 6 Type 6 - New Indication (no longer used) 17 TYPE 7 Type 7 - Drug Already Marketed without Approved NDA 18 TYPE 8 Type 8 - Partial Rx to OTC Switch 19 UNKNOWN 20 Unspecified 21 REMS REMS 22 TYPE 10 Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated 23 MEDGAS Medical Gas 24 TYPE 9 Type 9 - New Indication Submitted as Distinct NDA, Consolidated with Original NDA after Approval 25 TYPE 9- BLA Type 9 - New indication submitted as distinct BLA, consolidated 26 TYPE 4/5