Pharmaceutical Equivalents. Drug
products are considered pharmaceutical equivalents if they contain the
same active ingredient(s), are of the same dosage form, route of
administration and are identical in strength or concentration (e.g.,
chlordiazepoxide hydrochloride, 5mg capsules).
- Pharmaceutical Equivalents
- Pharmaceutical Alternatives
- Therapeutic Equivalents
Orange Book is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations; (2) approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs; (3) drug products with approval under Section 505 of the FD&C Act administered by the Center for Biologics Evaluation and Research; and (4) a cumulative list of approved products that have never been marketed, are for exportation, are for military use, have been discontinued from marketing and we have not determined that they were withdrawn for safety or effectiveness reasons, or have had their approvals withdrawn for other than safety or efficacy reasons subsequent to being discontinued from marketing.
Save some money with Computer app.
Now technology has made it possible for you and me to have an instantaneous answer to the question: “What are the generic equivalents to my brand name drug?” FDA very recently released a mobile app called Orange Book Express, or OB Express. The app is free to download and is available for the iOS and Android platforms.
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