combination product

A product composed of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined as a single entity.

A drug, device, or biological product packaged separately that is intended for use only with another approved individually specified drug, where both are required to achieve the intended use, indication, or effect.

Two or more separate products packaged together in a single package or as a unit.