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 xxxx://xxx.xxx.xxx/cder/ob/default.htm, or as the site address is amended.

Examples of Orange Book in a sentence

• Compound Drugs unless all of the ingredients are FDA-approved in the form in which they are used in the Compound Drug and as designated in the FDA’s Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, require a prescription to dispense, and the compound medication is not essentially the same as an FDA-approved product from a drug manufacturer.

• All materials furnished and work performed shall be done in accordance with the most current edition of the “Standard Specifications for Public Works Construction” (Orange Book) and any revisions thereto if not covered or amended by the Special Provisions.

• All materials furnished and work performed shall be done in accordance with the most current edition of the “Standard Details for Public Works Construction” (Orange Book) and any revisions thereto if not covered or amended by the Special Provisions.

• Also, until the Agency issues the final approval letter, this drug product will not be deemed approved for marketing under section 505(j) of the FD&C Act, and will not be listed in the Orange Book.

• The patents are listed with respect to VIMOVO in the Orange Book and expire at various times between 2014 and 2023.

More Definitions of Orange Book

Orange Book has the meaning set forth in Section 9.5.1.

Orange Book means the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations,” as may be amended from time to time.

Orange Book means "Approved Drug Products with Therapeutic Equivalence Evaluations", an FDA publication that is commonly referred to as the "Orange Book".

Orange Book has the meaning set forth in Section 7.6(b).

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 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 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.