Pharmaceutical

Pharmaceutical

Relating to the development, production and marketing of drugs that are legal and licensed for use as medication.

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Pharmaceutical > Drugs

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); ...

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 ...

medication guide

Pharmaceutical; Drugs

A medication guide contains information for patients on how to safely use a drug product.

new drug application (NDA)

Pharmaceutical; Drugs

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 ...

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 ...