New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing
Brand Name Drug means a Prescription Drug that has been given a name by a manufacturer or distributor to distinguish it as produced or sold by a specific manufacturer or distributor and may be used and protected by a trademark.
Generic Drug means any Prescription Drug approved by the FDA that has the same bio-equivalency as a specific Brand Name Drug.
FDA means the United States Food and Drug Administration.
Legend drug or "prescription drug" means any drug or device that has been determined to be unsafe for self- medication or any drug or device that bears or is required to bear the legend:
FDCA shall have the meaning ascribed to such term in Section 3.1(hh).
Prescription drug means any drug required by federal law or regulation to be dispensed only
Drug addiction means a disease characterized by a
Legend drugs means any drugs which are required by state
FD&C Act means the U.S. Federal Food, Drug and Cosmetic Act, as amended, and the regulations promulgated thereunder.
Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.