Orange Book definition

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 FDA’s publication, Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Orange Book means the FDA publication entitled “Approved Drug Products with Therapeutic Equivalence Evaluations” or any replacement thereof established or approved by the FDA.

Examples of Orange Book in a sentence

• 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.

• If a determination of the reason for discontinuation has not been published in the Federal Register (and noted in the Orange Book), you will need to research the archive file and/or consult with the review team.

• Were the products discontinued for reasons related to safety or effectiveness?YES NO (Information regarding whether a drug has been discontinued from marketing for reasons of safety or effectiveness may be available in the Orange Book.

• Did the applicant address (with an appropriate certification or statement) all of the unexpired patents listed in the Orange Book for the listed drug(s) relied upon to support approval of the (b)(2) product?YES NO If “NO”, list which patents (and which listed drugs) were not addressed by the applicant.

• Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.

More Definitions of Orange Book

Orange Book has the meaning set forth in Section 9.5.1.

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.

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 means the publication, Approved Drug Products with Therapeutic Equivalence Evaluations, in electronic or hard copy form, maintained by the FDA, including all supplements 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.