Glossary

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  • Strength

    The strength of a drug product tells how much of the active ingredient is present in each dosage. 

  • Supplement

    A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.

  • Supplement Number

    A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved.  To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).  Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.

  • Supplement Type

    Companies are allowed to make changes to drugs or their labels after they have been approved.  To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA).   The supplement type refers to the kind of change that was approved by FDA.  This includes changes in manufacturing, patient population, and formulation.