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What is the Orange Book?

Preface to the 41st Edition The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

What is a reference standard in the Orange Book?

In the electronic Orange Book, a reference standard is identified by “RS” in the RS column. The group or category of approved drugs. Format is RX, OTC, DISCN. The full name of the firm holding legal responsibility for the new drug application. The type of new drug application approval. New Drug Applications (NDA or innovator) are ”N”.

What is a Te code?

The TE Code indicates the therapeutic equivalence rating of generic to innovator Rx products. The date the product was approved as stated in the FDA approval letter to the applicant. The format is Mmm dd, yyyy. Products approved prior to the January 1, 1982 contain the phrase: "Approved prior to Jan 1, 1982".

What are the Therapeutic Equivalence Evaluations in the Orange Book?

The therapeutic equivalence evaluations in the Orange Book reflect FDA's application of specific criteria to the multisource prescription drug products listed in the Orange Book and approved under Section 505 of the FD&C Act. These evaluations are presented in the form of code letters that indicate the basis for the evaluation made.

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