supplement type
- Guideline or reference source
- FDA www.fda.gov
- Definition
- 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.
- Related Term
- supplement
- supplement to a new drug submission
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