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

tentative approval

Pharmaceutical; Drugs

If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the ...

therapeutic biological product

Pharmaceutical; Drugs

A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.

therapeutic equivalence (TE)

Pharmaceutical; Drugs

Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the ...

therapeutic equivalence (TE) codes

Pharmaceutical; Drugs

The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically ...

abbreviated new drug application (ANDA)

An abbreviated new drug application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval ...

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.

active ingredient

Pharmaceutical; Drugs

An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure ...