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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). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
A vial of Dopamine, labeled as "DOPamine HCl". Tall man lettering ( tall-man lettering or tallman lettering) is the practice of writing part of a drug 's name in upper case letters to help distinguish sound-alike, look-alike drugs from one another in order to avoid medication errors. [ 1][ 2] For example, in tall man lettering, "prednisone" and ...
Physicians' Desk Reference. The Physicians' Desk Reference ( PDR ), renamed Prescriber's Digital Reference after its physical publication was discontinued, is a compilation of manufacturers' prescribing information ( package insert) on prescription drugs, updated regularly and published by ConnectiveRx. [citation needed]
The Drugs@FDA area of the FDA’s site lets you see if there’s any generic version of your brand-name medicine. Eban is a fan of using the FDA site’s “Orange Book,” which lets you search ...
The following three lists of generic and genericized trademarks are: marks which were originally legally protected trademarks, but have been genericized and have lost their legal status due to becoming generic terms, marks which have been abandoned and are now generic terms. marks which are still legally protected as trademarks, at least in ...
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
An Abbreviated New Drug Application ( ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug . The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product.
t. e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to ...