Brand name drug

Brand name drug means a drug for which an application is approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 USC 355(c)), including an application referred to in section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (21 USC 355(b)(2)).

Source

42 CFR § 423.4

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Scoping language

The following definitions apply to this part, unless the context indicates otherwise:

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