Learn more about the FDA’s role in reviewing, approving, and monitoring drugs in the latest Search for FDA guidance documents, learn about the laws enforced by FDA, and more. From abbreviated new drug application to therapeutic equivalence codes, FDA defines it. Food and Drug Administration (FDA): Food additives and color additives that are listed in FDA regulations (21 CFR Parts 172, 173 and Parts 73, 74, 82 respectively), and flavoring substances evaluated by FEMA* and JECFA*. Some links in press announcements may no longer be active. Feb 13, 2025 · The Substances Added to Food inventory includes the following types of ingredients regulated by the U. Aug 6, 2025 · Contact FDA Get answers to your questions and report problems with FDA-regulated products. Jan 16, 2026 · Food and Drug Administration (FDA), agency of the U. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER Dec 12, 2025 · Info helps to master FDA’s list of Drug Master Files (DMFs) and info on submission of DMFs to agency. What’s the meaning of this? Welcome to the Drugs@FDA glossary of terms. (Type in all or part of the active ingredient name) Jan 12, 2024 · Common ingredients found in vaccines that are commonly administered to healthy babies, children and adults are discussed to determine their safety and effectiveness. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the Active Pharmaceutical Ingredient (API) Listing with FDA API (Active Pharmaceutical Ingredient) is any substance that is represented for use in a drug and that, when used in the manufacturing, processing, or packaging of a drug, becomes an active ingredient or a finished dosage form of the drug. The Data Dashboard contains data elements from FDA compliance and enforcement data sources, including Inspections, Compliance Actions, Recalls, Imports, and Food Safety Modernization Act programs. The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. The Food and Drug Administration (FDA) is a subdivision of the US Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The active ingredients in OTC medicines are clearly listed on the label, and the word “acetaminophen,” is listed on the front of the package or bottle and in the Active Ingredient section of the Drug Facts label. 1 day ago · Zyn is seeking FDA approval to say it’s less harmful than cigarettes Here’s what to know about public meeting concerning the nicotine pouches The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services. federal government authorized by Congress to inspect, test, approve, and set safety standards for foods and food additives, drugs, chemicals, cosmetics, and household and medical devices. Aug 19, 2024 · Find patient medical information for Ketoconazole topical (Nizoral, Xolegel, and others) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Explore pros and cons lists for debated issues presented in a non-partisan format with supporting background information, statistics, and resources. Asthma. Dec 5, 2024 · Find patient medical information for Fexofenadine (Allegra) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings Nov 27, 2024 · Fluticasone Flonase Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific nasal fluticasone products they stock. Sep 9, 2025 · The FDA created a green list of approved active pharmaceutical ingredients in the GLP-1 drugs to keep unverified ingredients out of the US. and monitors the safety of all regulated medical products. On prescription labels, acetaminophen is sometimes listed as “APAP,” “acetam,” or other shorted versions of the word. This information can be used by industry as an aid in developing drug products. U. 6MB) Unique Ingredient Identifier (UNII): To search for active ingredients, inactive ingredients or both, type in the alphanumeric code (s) for the ingredient (s) and select ingredient type from the dropdown menu Dec 12, 2025 · FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) identifies drug products approved on the basis of safety and effectiveness.

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