Tentative ApprovalIf a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA…
Therapeutic Biological ProductA therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.
Therapeutic Equivalence (TE)Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same…
Therapeutic Equivalence (TE) CodesThe coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as…
ToleranceA condition in which higher doses of a drug are required to produce the same effect achieved during initial use; often associated with physical dependence.
TranquilizersDrugs prescribed to promote sleep or reduce anxiety; the NSDUH classification includes benzodiazepines, barbiturates, and other types of CNS depressants.