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Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [3] [5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [2]
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
DrugBank: a comprehensive resource for in silico drug discovery and exploration. [1] The DrugBank database is a comprehensive, freely accessible, online database containing information on drugs and drug targets created and maintained by the University of Alberta and The Metabolomics Innovation Centre located in Alberta, Canada. [1] As both a ...
The national drug code (NDC) is a unique product identifier used in the United States for drugs intended for human use. The Drug Listing Act of 1972 [ 1 ] [ 2 ] requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed ...
e. Generally recognized as safe ( GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. [1] An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food ...
COVID-19. Pfizer. 3C-like protease inhibitor (Nirmatrelvir) / inhibition of metabolism of nirmatrelvir (ritonavir) Nevirapine. HIV. non- nucleoside reverse transcriptase inhibitor. Nitazoxanide. Broad-spectrum antiviral.
Lists of all drugs that have received orphan status in the United States and Europe are available from the U.S. Food and Drug Administration and the European Commission, respectively: FDA List of Orphan Designations and Approvals; European Commission Register of designated Orphan Medicinal Products
JANUS clinical trial data repository. Janus clinical trial data repository is a clinical trial data repository (or data warehouse) standard as sanctioned by the U.S. Food and Drug Administration (FDA). It was named for the Roman god Janus (mythology), who had two faces, one that could see in the past and one that could see in the future.
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