combination product

Noun

• 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.