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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

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 ...

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 ...

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 ...

abbreviated new drug application (ANDA)
Pharmaceutical; Drugs

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 ...

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 ...

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