Glossary

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  • Chemical Type

    The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation.  For example, Chemical Type 1 is assigned to an active ingredient that has never before been marketed in the United States in any form.  (list of Chemical Types and their meanings1)

  • Company

    The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.