combination product

combination product
a) A product comprised 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.
b) 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.

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