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

Abbreviated new drug application (ANDA) number

Pharmaceutical; Drugs

This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.

Approval letter

Pharmaceutical; Drugs

An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.

Generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended ...