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Orange Book

Definition

[21 U.S.C. § 355(j)(7)(A)(iii); 21 C.F.R. §314.53(c)(2)] Also referred to as the Approved Drug Products with Therapeutic Equivalence Evaluations, the Orange Book lists NDA-approved drugs and patent information.

Related Rules


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aaiPharma, Inc. v. Thompson


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Mylan Pharmaceuticals, Inc. v. Thompson