Module 1 — Container/Carton/Patient Labeling (OBX-319)

Document ID: M1-LBL
Version: 1.0
Change History: 1.0 — Initial issue.
Standard(s): 21 CFR 201/208; SPL

Container, Carton & Patient Labeling — OBX-319

The submission labeling set for OBX-319 beyond the prescribing information: immediate-container and carton labels (proprietary/nonproprietary name, strength, route [subcutaneous], storage, lot/expiry), a Medication Guide / Patient Package Insert, and, for the device presentation, Instructions for Use. In a US submission these are also provided as Structured Product Labeling (SPL) XML. 21 CFR 201; 208; SPL R8.