Drugs

Drugs

Terms in relation to substances, other than food, that have medicinal, intoxicating, performance enhancing, or other effects when put into the body of a human or animal.

Industry: Pharmaceutical

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Drugs

Snake oil

Pharmaceutical; Drugs

A substance that proclaims to have value, usually medicinal, that in fact has no beneficial effect whatsoever. It is sometimes extended to the phrase 'snake oil salesman' to refer to a person who ...

Marketing status

Pharmaceutical; Drugs

Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as: * Prescription * Over-the-counter * Discontinued * None - drug products ...

Generic drug

Pharmaceutical; Drugs

A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many ...

When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a ...

New drug application (NDA) number

Pharmaceutical; Drugs

This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage ...

Label

Pharmaceutical; Drugs

The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in ...

FDA application number

Pharmaceutical; Drugs

This number, also known as the NDA (new drug application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. One drug can have more than one ...