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In the United States, the Food and Drug Administration (FDA) determines the requirements for patient package inserts. In the United States, the FDA will occasionally issue revisions to previously approved package inserts, in much the same way as an auto manufacturer will issue recalls upon discovering a problem with a certain car.
DailyMed is a website operated by the U.S. National Library of Medicine (NLM) to publish up-to-date and accurate drug labels (also called a "package insert") to health care providers and the general public. The contents of DailyMed is provided and updated daily by the U.S. Food and Drug Administration (FDA). The FDA in turn collects this ...
This is a complete list of estrogens and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. Estrogens are used as hormonal contraceptives, in hormone replacement therapy, and in the treatment of gynecological disorders.
This greatly expanded and improved version of the database included 1344 approved small molecule drugs and 123 biotech drugs as well as 3037 unique drug targets. Version 2.0 also included, for the first time, withdrawn drugs and illicit drugs , extensive food-drug and drug-drug interactions as well as ADMET (absorption, distribution, metabolism ...
Monographs summarize the nomenclature, properties, actions, and uses of each substance. A chapter on supplementary drugs and other substances covers monographs on new drugs, those not easily classified, herbals, and drugs no longer clinically used but still of interest. Monographs of some toxic substances are also included.
Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
If a drug ingredient or drug product has an applicable USP quality standard (in the form of a USP-NF monograph), it must conform in order to use the designation "USP" or "NF". Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs.
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