Orange Book definition
Orange Book means the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.
Orange Book means the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, as may be amended from time to time.
Orange Book means the Approved Drug Products book published by the FDA most recently and for subsequent years during the term of this Agreement, including its printed, monthly supplements, and the electronic version of the Orange Book found at ▇▇▇▇://▇▇▇.▇▇▇.▇▇▇/cder/ob/default.htm, or as the site address is amended.
Examples of Orange Book in a sentence
Eureka will have the full and exclusive right, in its sole discretion, to determine and control the listing of any Eureka Controlled Patent Right in the then-current patent listing that is equivalent to the Orange Book or the Purple Book in any country of the Eureka Territory in connection with the Regulatory Approval of any Licensed Product for the Eureka Territory.
More Definitions of Orange Book
Orange Book has the meaning set forth in Section 9.5.1.
Orange Book has the meaning set forth in Section 7.6(b).
Orange Book means "Approved Drug Products with Therapeutic Equivalence Evaluations", an FDA publication that is commonly referred to as the "Orange Book".
Orange Book means the electronic or hard copy version of the FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, and any successor or equivalent publication thereto.
Orange Book means the latest edition of the “Standard Specifications Book for Public Works Construction” sponsored and distributed by the Regional Transportation Commission in conjunction with City and other governmental entities. Further, public works construction shall be completed in a diligent and workmanlike manner of good quality free from faults and defects.
Orange Book means the United States Food and Drug Administration's "Approved Drug Products with Therapeutic Equivalence Evaluations" publication and its cumulative supplements, which include a list of approved prescription drug products with therapeutic equivalence evaluations.
Orange Book means the publication Approved Drug Products with Therapeutic Equivalence Evaluations that identifies drug products approved on the basis of safety and effectiveness by the FDA under the FFDCA.