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.
- Browse Related Terms: Approval History, Discontinued Drug Product, FDA Action Date, label, Marketing Status, Reference Listed Drug (RLD), Route, Supplement, Supplement Number, Supplement Type, Tentative Approval