The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, is its catalog of all approved chemical products. The two agencies said Sept. 14 that ...

Unlike technical standards such as 5G, as to which tens of thousands of patents held by a hundred or more companies have been declared as essential, the approved drug products in the Orange Book ...

The Orange Book is a list of drugs that the U.S. Food and Drug Administration (FDA) has approved as both safe and effective.

The FDA added two different dose formulations of this generic dapagliflozin, 5 mg and 10 mg, to the agency's list of Approved Drug Products With Therapeutic Equivalence Evaluations, a publication ...

The FDA has changed the therapeutic equivalence rating for this product in the Agency’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) from AB to BX, signifying ...

Phexxi is currently protected by four patents, each of which are listed in the FDA's publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the 'Orange Book.' ...

“Submissions for drug products for which there is only approved product listed in the Prescription Drug Product List…of FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations ...

The Orange Book, formerly known as the Approved Drug Products with Therapeutic Equivalence Evaluations, was first published in 1980. The updated website features a new design with more user ...

These improvements result in patents, which may be valid improvements or inappropriately applied to the drug. Either way, these patents are required to be filed in the Approved Drug Products with ...

In order to discuss the appropriateness of substituting one drug for another, it is important to understand certain key terms. [10] Pharmaceutical equivalents are drug products containing the same ...