2025年1月10日 · Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.

2025年2月6日 · Preface to Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) provides info on how the book came to be, relevant terms and codes, user responsibilities and more.

2023年1月11日 · The draft guidance explains the criteria FDA uses to evaluate the therapeutic equivalence (TE) of drug products and what the TE codes indicate.

2023年11月21日 · Therapeutic equivalence (TE) is specifically defined by the FDA and has very strict criteria for a drug to meet. In order to be therapeutically equivalent, two or more FDA approved drugs must...

Therapeutic Equivalence Evaluations PREFACE TO THIRTY EIGHTH EDITION . The publication, Approved Drug Products With Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug products approved on …

2022年7月20日 · To be considered therapeutically equivalent to another drug, a product must be pharmaceutically equivalent, bioequivalent and have the same clinical effect and safety profile.

2024年10月1日 · Explore therapeutic equivalence in pharmaceuticals, its benefits, challenges, and future trends. Learn how it ensures safe and effective drug substitutions.

Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act).

2025年3月4日 · Checking Therapeutic Equivalence. The best resource for determining therapeutic equivalence for human drugs is the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly called the Orange Book.

2025年1月14日 · With routine cGMP inspections and Annual Product Reviews, the industry and FDA can confer the assurance with evidence of therapeutic equivalence over the commercial lifespan of pharmaceutical products. A totality-of-evidence approach provides a sustainable framework for all [generic] drug products.